Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
Phase: NA
Conditions: Trauma Injury, Airway Control
Sponsor: Jason Sperry

LITES TO5 (PACT) Protocol v7 2/13/2023 
 
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Task Order 0005 
 
Prehospital Airway Control Trial (PACT) 
PROTOCOL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VERSION 7 
2/13/2023 
 
 
 
 

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Table of Contents 
PROTOCOL SYNOPSIS ................................................................................................................ 4 
1. 
OBJECTIVE, SPECIFIC AIMS, BACKGROUND, AND SIGNIFICANCE ................... 5 
1.1 
OBJECTIVE .................................................................................................................................. 5 
1.2 
SPECIFIC AIMS ........................................................................................................................... 5 
1.3 
BACKGROUND and SIGNIFICANCE ........................................................................................ 5 
2. 
RESEARCH DESIGN AND METHODS ............................................................................. 6 
2.1 
CLASSIFICATION AND METHODOLOGICAL DESIGNS ...................................................... 6 
2.1.1 
Randomization .............................................................................................................. 7 
2.2 
BRIEF DESCRIPTION OF STUDY DESIGN ............................................................................. 8 
2.3 
COORDINATION OF STUDY .................................................................................................... 8 
2.3.1 
Clinical Coordinating Center (CCC) ............................................................................. 8 
2.3.2 
Data Coordinating Center (DCC) ................................................................................. 8 
2.3.3 
Training and Participating Site Coordination ................................................................ 8 
2.4 
STUDY DEVICES ........................................................................................................................ 9 
2.4.1 
Study Device Dispensing .............................................................................................. 9 
2.4.2 
Device Selection ........................................................................................................... 9 
2.4.3 
Device Accountability .................................................................................................. 9 
2.4.4 
Rescue Strategy ............................................................................................................. 9 
2.5 
STUDY ENDPOINTS ................................................................................................................... 9 
2.6 
STATISTICAL ANALYSIS ....................................................................................................... 10 
2.6.1 
Statistical Analysis Plan .............................................................................................. 10 
2.6.2 
Sample Size Determination ......................................................................................... 12 
2.6.3 
Predefined Subgroups ................................................................................................. 12 
2.6.4 
Enrollment of Ineligible Patients ................................................................................ 12 
2.6.5 
Non-Adherence ........................................................................................................... 12 
2.6.6 
Interim Analyses ......................................................................................................... 12 
2.6.7 
Handling Missing Data ............................................................................................... 13 
2.6.8 
Data Management ....................................................................................................... 13 
2.6.9 
Data Elements ............................................................................................................. 14 
2.7 
QUALITY CONTROL, ASSURANCE, AND CONFIDENTIALITY ....................................... 15 
2.7.1 
Protocol Compliance ................................................................................................... 15 
2.7.2 
Protocol Deviations and unexpected problems: .......................................................... 15 
2.7.3 
Privacy and Confidentiality: ....................................................................................... 15 

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2.7.4 
Investigator Responsibilities ....................................................................................... 15 
3. 
HUMAN SUBJECTS ............................................................................................................ 15 
3.1 
SUBJECT POPULATION .......................................................................................................... 16 
3.2 
INCLUSION CRITERIA ............................................................................................................ 16 
3.3 
EXCLUSION CRITERIA ........................................................................................................... 16 
4. 
IRB APPROVAL AND FDA AMENDMENTS .................................................................. 17 
5. 
ENROLLMENT AND INFORMED CONSENT PROCEDURES .................................. 17 
5.1 
ENROLLMENT METHODS: ..................................................................................................... 17 
6. 
DATA AND SAFETY MONITORING ............................................................................... 18 
6.1 
DATA SAFETY MONITORING BOARD ................................................................................. 18 
6.2 
DATA SAFETY MONITORING PLAN .................................................................................... 19 
6.2.1 
Parameters to be Monitored ........................................................................................ 19 
6.2.2 
Frequency of Monitoring ............................................................................................ 19 
6.3 
REPORTABLE ADVERSE EVENTS ........................................................................................ 20 
6.3.1 
Adverse Events Reporting Timeline ........................................................................... 20 
6.4 
RISKS MANAGEMENT PROCEDURES ................................................................................. 20 
6.4.1 
Protection Against Risks of Data Collection .............................................................. 20 
6.5.2 Protection Against Potential Risks of Experimental Intervention .................................. 21 
7. 
COSTS ................................................................................................................................... 21 
8. 
REFERENCES ..................................................................................................................... 21 
Appendix I – Study Sites .............................................................................................................. 23 
Appendix II – PACT EFIC PLAN .............................................................................................. 23 
 
 

 
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PROTOCOL SYNOPSIS 
 
Protocol Title: 
LITES Task Order 0005 Prehospital Airway Control Trial (TO-5 PACT) 
Protocol Number: 
STUDY20110369 
NCT Number: 
NCT 04100564 
Version # and Date: 
Version 7 dated 2/13/2023 
Investigational Devices: 
i-gel, King, LMA (Supreme and Unique) 
Trial Sites: 
• 
University of Pittsburgh, University of Pittsburgh Medical Center, PI 
Jason Sperry, Co-PI Frank Guyette 
• 
Additional sites: Please see Appendix I 
IDE Sponsor: 
Jason L Sperry, MD, MPH 
Study Aims: 
AIM#1: To compare the effect of a standard strategy of airway 
management vs. a strategy of first attempt with supraglottic airway (SGA) 
upon 24- hour survival after traumatic injury. 
AIM#2: To compare the effect of a standard strategy of airway 
management vs. a strategy of first attempt with supraglottic airway 
(SGA) upon hospital survival after traumatic injury. 
AIM#3: To compare the effect of a standard strategy of airway 
management vs. a strategy of first attempt with supraglottic airway 
(SGA) upon major adverse events after traumatic injury. 
Study Design: 
Open label, multi-center, stepped wedge randomized trial comparing a 
standard airway management strategy and a strategy of initial use of 
SGA for airway management of prehospital trauma patients 
Planned Sample Size: 
2,009 
Planned Study Time: 
5 year study with 4 years of enrollment 
Major Inclusion 
Criteria: 
1. Traumatic injury requiring advanced airway management 
2. Transporting (or intended transport) to an enrolling LITES Trauma Center 
Major Exclusion 
Criteria: 
1. Less than 15 years of age 
2. Pregnancy 
3. Prisoner 
4. Initial advanced airway attempted by non-PACT provider 
5. Cardiac Arrest without return of spontaneous circulation (ROSC) at the 
time of the intervention 
6. Caustic substance ingestion 
7. Airway burns 
8. Objection to study voiced by subject or family member at the scene 
Primary Endpoint: 
24-hour survival 

 
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1. OBJECTIVE, SPECIFIC AIMS, BACKGROUND, AND 
SIGNIFICANCE 
 
1.1 OBJECTIVE 
Compare standard strategies of advanced airway management to a strategy of initial 
supraglottic airways in trauma patients within the prehospital setting. 
 
1.2 SPECIFIC AIMS 
Airway, Breathing, and Circulation (ABC) support is the prevailing strategy for 
the management of trauma. Current trauma resuscitation guidelines rank airway 
management among the highest clinical priorities1. The standard approach to prehospital 
advanced airway management is endotracheal intubation (ETI). However, ETI is 
difficult and error-prone2,3. Delays in airway management have been associated with 
increased morbidity and mortality. The use of ETI in trauma cases is controversial, and 
ETI is associated with increased mortality in traumatic brain injuries (TBI)4,5. Intubation 
requires a high burden of training and most Emergency Medical Services (EMS) 
personnel have limited ETI skill and experience6,7. 
Alternatives to standard advanced airway management include supraglottic airways 
(SGA) such as the laryngeal tube, i-gel, and laryngeal mask airway. Compared with 
standard management, SGAs are simpler to insert, an easier skill to learn, and can 
provide adequate ventilation8-10. However, the comparative effectiveness of prehospital 
SGA and standard management in trauma patients is unknown. 
LITES Task Order 0005 aims to compare different strategies of trauma airway 
management in the prehospital setting with the following aims: 
 
AIM #1: To compare the effect of a standard strategy of airway management vs. a 
strategy of first attempt with supraglottic airway (SGA) on 24-hour survival after 
traumatic injury. 
 
Hypothesis #1: The null hypothesis is that 24-hour survival is similar between 
standard strategy and initial SGA strategy. 
 
AIM #2: To compare the effect of a standard strategy of airway management vs. a 
strategy of first attempt with supraglottic airway (SGA) on hospital survival after 
traumatic injury. 
 
Hypothesis #2: The null hypothesis is that hospital survival is similar between 
standard strategy and initial SGA strategy. 
 
AIM #3: To compare the effect of a standard strategy of airway management vs. a 
strategy of first attempt with supraglottic airway (SGA) on major adverse events. 
 
Hypothesis #3: The null hypothesis is that the incidence of major adverse events 
is similar between standard strategy and initial SGA strategy. 
 
1.3 BACKGROUND and SIGNIFICANCE 
Prehospital trauma airway management is a low frequency, high consequence event 

 
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for both military and civilian providers. Airway management failures account for 8 to 15% 
of combat deaths deemed to be potentially preventable11-13. Prehospital airway 
management consists of some combination of basic airway maneuvers and bag valve 
mask (BVM) ventilation to temporize the patient, followed by advanced management 
with either ETI, SGA, or a surgical airway (SA) procedure. While ETI is the gold 
standard in prehospital airway management, its safety and efficacy have been questioned, 
particularly following trauma and traumatic brain injury5. However, other investigators 
have demonstrated associations between survival and ETI in trauma patients, resulting in 
equipoise based on the existing literature11. 
In both civilian and military prehospital environments, the acquisition and 
maintenance of the skills necessary for airway management are exceptionally difficult. 
Previous studies on ETI have indicated that prehospital providers require 10 or more 
intubations to obtain proficiency and approximately 5 to 12 intubations per year to 
maintain proficiency7. Yet, the average prehospital provider performs fewer than two 
interventions per year6. Lairet et al. describe ETI as the most frequently missed lifesaving 
intervention, accounting for 53% of missed interventions in combat12. The reasons 
for ETI failure are complex and include patient, provider, and environmental factors13. 
The current alternative used in military airway management is surgical airway 
procedures. While these account for only 1.8% of military prehospital airway procedures, 
they account for 12% of missed lifesaving interventions. While the success of the 
procedure is as high as 82%, SA is also a rare procedure for which training and experience 
are limited12. 
SGAs have been shown to require less time and less practice to achieve 
proficiency to place8,9. Although older devices performed poorly in military use, newer 
devices may have several advantages over standard management strategies, including ETI. 
The devices in the newer generation have simplified insertion procedures, lack balloons, 
do not require syringes for inflation, and 
have ports that allow for venting and 
decompression of the stomach. 
In addition to their speed and ease of use, SGAs can be placed blindly without the 
need for the additional equipment required for a laryngoscopy. In tactical situations, blind 
insertion techniques may limit tactical exposure and improve light discipline14. SGAs 
have been associated with shorter prehospital scene times, which may translate into 
reduced risk for the provider and decreased patient mortality. Use of SGAs may also be a 
less perishable skill than the use of ETI, allowing for better retention and faster pre-
deployment training. 
 
 
2. RESEARCH DESIGN AND METHODS 
 
2.1 CLASSIFICATION AND METHODOLOGICAL DESIGNS 
We propose the LITES Task Order 0005 Prehospital Airway Control in Trauma 
(PACT) trial, a 5-year (4-year enrollment), open label, multi-center, stepped wedge 
randomized trial comparing standard airway management strategy and a strategy of 
initial use of SGA for the airway management of prehospital trauma patients (Figure 1). 
The trial will be carried out at sites within the LITES Network. The LITES Network 
is an operational trauma center consortium with the expertise, track record, and 
confirmed capabilities to conduct prospective, multicenter, injury care and outcomes 
research relevant to the U.S. Department of Defense. 

 
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2.1.1 Randomization 
PACT will employ a stepped wedge design (Figure 2) in which all 
participating EMS agencies transition from the control arm, standard airway 
management strategy, to the intervention arm, initial SGA strategy, with some 
agencies applying the intervention before others15. Once an agency has 
stepped to the initial SGA arm, they will remain assigned to this 
arm for the remainder of the study. Blinding is not possible with this 
intervention. This trial design allows us to perform a pragmatic trial for an 
intervention strategy that has agency level variation as a result of differences in 
provider makeup (EMT/paramedic, dual paramedic, paramedic/nurse), transport 
mode (air/ground), the availability of rapid sequence intubation (RSI), the use 
of adjuncts (oropharyngeal and nasopharyngeal airways, tracheal introducers, 
video laryngoscopy), and training. 
The trial will be conducted over approximately 48 months with 17 
prehospital agencies crossing from standard care arm to intervention arm in one of 
seven periods. 287 subjects will be enrolled in each enrollment period, before 
stepping to the next enrollment period. This will continue until 1,722 subjects are 
enrolled, when all prehospital agencies will be exposed to the intervention arm. 
 
Figure 2. Schematic illustration of the PACT stepped wedge randomized trial with six steps. 
 
 
 
 
Approx. time 
Year 1 
Year 2 
Year 3 
Year 4 
Enrollment 
period → 
 
Step number  
287 
subjects 
574 
subjects 
861 
subjects 
1,148 
subjects 
1,435 
subjects 
1,722 
subjects 
2,009 
subjects 
1 
 
 
 
 
 
 
 
2 
 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
5 
 
 
 
 
 
 
 
6 
 
 
 
 
 
 
 
 
Standard care (control arm) 
 
Initial SGA (intervention arm)   
Pre-enrollment 
period 
Year 2 
Year 3 
Year 4 
Year 5 
Figure 1. Time Table 
Enrollment 
FDA IDE, 
Central IRB 
approval, 
Community 
Consent 
Step 2 
Interim 
Analysis 
Step 5 
Interim 
Analysis 
Site Training 
1st 3 Months

 
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2.2 BRIEF DESCRIPTION OF STUDY DESIGN 
 
Standard Care Arm: Airway management in the standard care arm of this pragmatic trial will be 
dictated by local protocols. We will accrue data on all participants who met all the inclusion criteria 
and none of the exclusion criteria regardless of which airway management strategy is utilized. 
 
Initial SGA Arm: EMS agencies randomized to the intervention arm will follow a strategy of initial 
advanced airway management with an SGA. Airway management of eligible subjects will be initiated 
at any time between EMS initial contact and the transfer of care to the receiving trauma center. Only 
the initial advanced prehospital airway management strategy is dictated by the study protocol; all 
other interventions, including preparation and subsequent attempts at advanced airway management, 
will be dictated by local protocols. 
 
In the event that a prehospital provider is unable to complete preparations, such as bag valve mask 
ventilation, and place an advanced airway, the subject will be retained and analyzed according to the 
intended arm assignment. 
 
In both arms, study data will be abstracted from EMS records, including indications for airway 
management, vital signs, use of adjuncts, pharmacological treatment, and timing of interventions and 
will be entered into an electronic data management system. 
 
2.3 COORDINATION OF STUDY 
 
2.3.1 Clinical Coordinating Center (CCC) 
Clinical Coordination specific to the PACT trial will be performed by LITES Network 
Coordinating Center and its dedicated research team at the University of Pittsburgh. The CCC’s 
responsibilities include all regulatory requirements, provider and coordinator training, and clinical 
monitoring. 
 
2.3.2 Data Coordinating Center (DCC) 
Data Coordination specific to the PACT trial will be performed by the Epidemiology Data 
Center (EDC), led by Dr. Wisniewski at the Graduate School of Public Health at the University 
of Pittsburgh. The DCC will design data collection forms, build and maintain an electronic data 
management system, provide training and technical assistance for site-based data entry personnel, 
develop and implement quality control mechanisms (including in-person and remote monitoring), 
and produce reports. The DCC will also plan, coordinate, and carry out all statistical analyses and 
make the datasets available for public use after the trial is over. 
 
2.3.3 Training and Participating Site Coordination 
The CCC is responsible for all research coordinator training and prehospital provider training. 
Research coordinators, prehospital providers, and associated staff will be trained during the months 
prior to the trial start date on the scientific basis for the trial, specific inclusion and exclusion 
criteria, data collection and processing, prehospital procedures, and standard operating procedures 
(SOPs). Training verification and retraining will occur if new staff members are hired at individual 
participating sites. Trial enrollment will be tracked monthly using the web-based data platform. 
Screening, enrollment, and data completeness and accuracy will be assessed via a site visit (in-
person or remotely) initially after the first three subjects are enrolled.  Subsequent monitoring visits 
will then occur at least twice annually. 

 
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During the site initiation visit and the visit prior to the site switching strategies, we will review 
the participating EMS agencies’ airway protocols. Specifically, we will reinforce the assessment 
and treatment of inadequate ventilation using an advanced airway.  We will review recognition 
and treatment of incorrect placement of the device, dislodgements, air leak and possible 
laryngospasm. We will review strategies for management of patients who have vomited at any 
time during the prehospital period including suctioning and gastric decompression following the 
placement of the advanced airway. We will address sedative and analgesic medication 
administration to facilitate advanced airways in accordance with the EMS agencies’ local 
protocols. All EMS agencies will review absolute and relative contraindications to advanced 
airway placement including but not limited to caustic ingestion, inability to open the mouth, and 
gagging on insertion of the device.  
 
2.4 STUDY DEVICES 
2.4.1 Study Device Dispensing 
As part of the pragmatic design of the study, prehospital services will continue to utilize 
the specific airway management devices that are already in use and in supply at their respective 
agencies. Although the SGAs used on enrolled subjects during the interventional arm will be considered 
investigational devices, they will not be provided by the study. 
 
2.4.2 Device Selection 
The study will focus on airway management strategies using second generation SGAs as our 
intervention. Second generation SGAs have fewer fail points than the previous devices. Additionally, 
prehospital providers have a higher first pass success rate and novice users generally find the devices 
easier to place, decreasing the amount of training required and lessening the burden of skill 
maintenance. SGAs employ a rapid, blind technique for placement that requires less equipment then 
endotracheal intubation. SGAs also provide a less invasive airway management strategy which may 
allow the provider to focus on other time dependent tasks. 
To emphasize the comparison of the airway management strategy rather than the individual 
device, EMS agencies will continue to use the device they currently have in service. As a pragmatic 
trial we will not ask them to change devices or training regimens. We plan a priori subgroup 
analyses to examine differences in SGA type used within the intervention strategy. 
 
2.4.3 Device Accountability 
SGAs used in enrolled subjects will be tracked per FDA requirement. As these devices are 
already in use by the prehospital services per their standard care protocols and will not be provided to 
the agencies by the study, we will only be tracking the individual devices that are used in enrolled 
subjects in the investigational arm. Tracking of these study devices will be consistent with record-
keeping and other responsibilities as required under 21 CFR 812. 
 
2.4.4 Rescue Strategy 
Only the initial attempt at advanced airway management is dictated by study protocol. All 
subsequent attempts at management will be at the provider’s discretion and will be based on local 
protocol. 
 
2.5 STUDY ENDPOINTS 
 
Primary Outcome: The primary outcome for the trial is 24-hour survival. 

 
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Secondary Outcomes: Secondary outcomes include survival to hospital discharge, expected clinical events 
(including incorrect placement of the airway, inadequate ventilation, airway trauma, or concern for aspiration 
as defined as documented vomiting and/or need for suctioning), airway management performance (including 
initial pass success, overall success, and use of rescue technique), ICU length of stay, ventilator days, and 
expected adverse events including airway trauma, pneumothorax, incidence of acute respiratory distress 
syndrome (ARDS) and incidence of ventilator associated pneumonia (VAP).  
 
Primary Outcome Definition: 
24-hour Mortality: A binary variable defined as death within 24 hours 
 
Secondary Outcome Definitions: 
 
Secondary outcomes will be assessed from arrival at the trauma center through day 30 or discharge, 
whichever is first. 
 
In-Hospital Mortality: A binary variable defined as death recorded any time after hospital arrival. 
 
Airway Management Performance: The elements of airway management performance include 
airway misplacement (including endotracheal tube misplacement), initial pass success (the successful 
placement of device on the first attempt past the teeth confirmed by EtCO2), sequence of airway 
insertion, airway insertion success and time, number of airway insertion attempts, inadequate 
ventilation, and any instances of airway conversion (change of airway in the first 24 hours). 
 
Acute Respiratory Distress Syndrome (ARDS): The Berlin definition for mild ARDS (PaO2/FIO2 
≤ 300 mm Hg plus timing, imaging, and origin criteria) will be utilized as a threshold value to 
determine the incidence of ARDS within 24 hours of presentation. We will further stratify patients 
into mild, moderate (PaO2/FIO2 ≤ 200 mm Hg), or severe (PaO2/FIO2 ≤ 100 mm Hg) ARDS.16 
 
ICU length of stay (LOS): Defined as the number of days spent admitted to the Intensive Care Unit. 
ICU LOS will be recorded to the first decimal place. 
 
Ventilator Days: Defined as number of days on a mechanical ventilator. Ventilator days will be 
recorded to the first decimal place. 
 
Ventilator Associated Pneumonia: A binary variable defined as VAP in the first 24 hours as evident 
by a new infiltrate on chest image and ≥1 of the following: temp >38 or less than 36 degrees C, WBCs 
>12,000, purulent secretions from the airways and or reduction in gas exchange (PaO2/FIO2 ≤ 300 mm 
Hg). (Michetti Trauma 2012) 
 
Other Adverse Events:  Binary variables defined as the onset of one of the following adverse events in 
the first 24 hours after enrollment: oropharyngeal trauma, hypopharyngeal trauma, pneumothorax, 
aspiration pneumonitis, ARDS, and VAP. 
 
 
2.6 STATISTICAL ANALYSIS 
 
2.6.1 Statistical Analysis Plan 
The analyses will describe the baseline demographic and clinical characteristics of the overall 

 
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population first by randomization unit (agency or combination of agencies), and then stratified by 
airway management strategy (standard management compared to initial SGA). A separate analysis for 
each step will be performed. For discrete variables, proportions will be generated and a chi-square test 
will be used to test for differences between the proportions. For continuous characteristics, means 
(medians) and standard deviations (interquartile ranges) will be calculated and t-tests (Wilcoxon) will 
be used to compare the means (distributions) among those with standard airway management vs. those 
managed by initial SGA. Variables that are imbalanced will be included as a covariate in multivariable 
models when assessing the association between strategy and outcomes. 
We will calculate the difference in outcomes divided by the estimated “robust” standard error 
based on the Huber-White sandwich estimator in order to account for within-randomization unit 
correlation and variability, which might depart from the classical assumptions. To quantify the treatment 
effect, we will calculate the 95% confidence interval for the difference in event rates. We will perform 
the analysis on an intention-to-treat (primary analysis) and treatment-received (secondary analysis) 
bases. 
 
Hypothesis #1: For the primary outcome, an indicator of death within 24 hours will be 
generated for each participant. A generalized linear mixed model (i.e. logistic regression model) 
will be used to assess the independent impact of initial SGAs on 24-hour survival, with a 
random effect of randomization unit a fixed effect for each step, and fixed effects of airway 
management (standard vs. initial SGA) and the potential confounding effects of baseline 
characteristics. The estimated intra-randomization unit correlation and time effect from this 
model will be reported to help design future randomized trials and to describe the potential 
confounding effects of calendar time. For time-to-event data, a mixed effects Cox-proportional 
hazards regression model will be used to assess the independent impact of airway management 
strategy on time to death, with randomization unit as a random effect and step, airway 
management strategy, and the potential confounding effects of baseline characteristics not 
balanced through random assignment as fixed effects. 
 
Hypothesis #2: The same analytic approach that was carried out for hypothesis #1 will be 
implemented, but the outcome of interest will be survival to hospital discharge. 
 
Hypothesis #3: The analytic approach for the secondary outcomes will vary based on the type 
of outcomes. For binary outcomes (e.g., 24-hour and in hospital mortality, ventilator associated 
pneumonia, and post-traumatic ARDS), the same analytic approach that was carried out for 
Hypothesis #1 will be implemented. For continuous outcomes (e.g., hypotension or hypoxia 
dose) a generalized 
linear mixed model (i.e., linear model) will be used to assess the 
independent effect of airway management strategy on outcome, with a random effect of 
randomization unit, a fixed effect for each step, and fixed effects of airway management strategy 
(standard airway versus initial SGA) and the potential confounding effects of baseline 
characteristics. 
 
Subgroup Analysis: The general approach to assessing the homogeneity of a treatment effect 
across subgroups will be to include an interaction term between the use of airway management 
strategy (standard versus initial SGA) and the characteristics defining the subgroup in the 
regression model. A statistically significant interaction term would indicate that the null 
hypothesis of a homogenous effect can be rejected, indicating a differential effect from airway 
management strategy across the subgroups. For example, when examining the homogeneity of 
the effect of airway management strategy on the primary outcome among those with and 
without a TBI, the logistic model will be modified to include a main effect for TBI and the two-

 
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way interaction between airway management strategy and TBI. 
 
2.6.2 Sample Size Determination 
This stepped wedge randomized control trial will use 24-hour mortality as its primary outcome 
to power the trial. This sample size was calculated using the formula presented by Hemming  and  
Taljaard  and  takes  into  account  the  design  feature  that  airway management strategy will be 
switched from standard care to initial SGA sequentially by 17 prehospital agencies over 7 time periods 
(6 steps).17 The intra-randomization unit correlation coefficient (ICC) for the primary outcome was 
assumed to be 0.025 based on preliminary data from Pittsburgh’s prehospital agencies. To detect a 
decrease from 16.7% to 9.7% (a difference of 7%), with 80% power at 5% significance level, a sample 
size of 1,904 will be required.  To account for 5% dropout, we will need to enroll 118 participants from 
each of the 17 prehospital agencies over the seven enrollment periods (17 participants per agency per 
period). Therefore, the total required sample size is 2,006, however, to enroll equal numbers of patients 
in each enrollment period, we will enroll 2,009 patients. 
 
2.6.3 Predefined Subgroups 
Predefined subset analyses will be performed on: 1) participants with drug assisted advanced 
airway management, 2) participants treated by air medical services as compared to ground services, 3) 
services with video laryngoscopy, 4) participants with significant traumatic brain injury (Head Acute 
Injury Score (AIS) > 2) versus those without significant brain injury (Head AIS ≤ 2), 5) participants 
enrolled from the scene of injury versus those enrolled from a referral hospital, 6) participants who 
suffered blunt injury as compared to those who suffered penetrating injury, 7) participants with 
high versus low field to ED transport times (median split subgroups), 8) participants with BLS airway 
management prior to arrival the of the PACT participating agency, and 9) participants that were in 
arrest at the time of enrollment that achieved return of spontaneous circulation (ROSC). 
We recognize that the trial is not appropriately powered for these subgroup comparisons; 
therefore, the results and conclusions formulated from these subgroup analyses will be considered 
exploratory in nature and will not be used as a basis for treatment recommendations. 
 
2.6.4 Enrollment of Ineligible Patients 
It is anticipated that there will be a small proportion of patients who are deemed eligible by a 
participating EMS agency and treated with the intent to enroll but are later determined to have been 
ineligible. In this circumstance, an intent to treat principle will be followed, dictating that their data be 
analyzed according to the intended arm of treatment.  Subgroup analyses based on eligibility criteria 
will be performed if the number of ineligible patients is large.  
 
2.6.5 Non-Adherence 
In some circumstances, subjects may receive standard care instead of an initial SGA when on 
the treatment arm.  In keeping with the intention-to-treat analytic design, these participants will be 
analyzed according to the intended arm of treatment. 
 
2.6.6 Interim Analyses 
Prior to initiation, and in concert with the DSMB, the final monitoring plan will be developed to 
serve as a guide to the DSMB’s decision-making process concerning early stopping of the trial. In making 
the decision to recommend termination of the trial, the DSMB will be guided by information on safety 
outcomes by treatment group. 
Two interim safety analyses will be conducted, one at the completion of the second step (third 
period) and one at the completion of the fourth step (fifth period, out of seven periods).  The frequency of 
the composite safety outcome (mortality, failure to place an advanced airway on first attempt, failure to 

 
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ventilate) in the two groups will be summarized.  The null hypothesis that there is no difference in the 
proportion of the rate of the composite safety outcome between the two groups will be tested using a 
generalized linear mixed model.  Group sequential methods, such as a Lan and Demets approach with an 
O’Brien and Fleming spending function will be used to ensure that the overall type I error rate of 0.05 is 
maintained across the three tests (two interim and one final), with the majority of the type I error reserved 
for the final test. Based on the expected recruitment of 287 participants per period (2,009/7 periods), we 
expect a sample size of 861 for the first interim analysis (information fraction of 43%) and 1,435 for the 
second interim analysis (information fraction of 71%). For the first interim analysis the upper/lower 
boundaries will be +/- 3.22 with a nominal alpha level of 0.001. The second interim analysis will have 
upper/lower boundaries of +/- 2.42 with a nominal alpha level of 0.015. The final analysis will have 
upper/lower boundaries of +/- 2.00 with a nominal alpha level of 0.045.  
Further—and in relation to the interim safety analyses—safety data by group will be 
provided periodically to the DSMB. Safety data serious adverse events include frequency, a 
description of each event, and the date of each event. 
 
2.6.7 Handling Missing Data 
The general strategy for missing data will concentrate on a tactical approach rather than only on 
an analytical one. The goal is to prevent missing data as much as possible because there is no analytical 
methodology that can recover the robustness and unbiased character of estimates derived from a 
complete case scenario. We expect very little missing data due to the nature of the trial design and 
related preparation and efforts to realize a well-conducted clinical trial. Because the intervention spans 
a short time and takes place mostly during the prehospital phase, we do not expect a considerable 
dropout during the treatment phase. Because we expect about 5% dropout, we have inflated the sample 
size by 5% to reduce the related effect on power adequacy. 
For interim and final analyses, we will use multiple imputation for the final value for participants 
whose 24-hour mortality cannot be determined. For sensitivity analyses, we will report the data with 
and without multiple imputation. We will also report an analysis consistent with that used in other 
trauma studies, which count those with missing data as ‘alive’ and ‘dead’ using the overall mortality 
rate for the trial at 24 hours.  Missing data will be documented along with the related causes, 
continuously monitored, and mitigated accordingly.  The electronic data management system prevents 
study personnel from skipping questions and requires an appropriate missing data code.We will assume 
that data are not missing at random. A likelihood-based analysis, including regression, multiple 
imputations, and random-effects regression models could be implemented in this regard. Missing 
outcomes can be predicted from individuals’ observed data using models based on observed 
individuals. The final analyses will explicitly state the assumptions underlying the treatment of missing 
outcomes and explain the use of compressive data descriptions and sensitivity analysis. Sensitivity 
analysis will allow us to explore the robustness of conclusions compared to alternative plausible 
assumptions. We will follow the CONSORT statement in reporting the number of randomization units 
with missing outcome data by treatment arm.18 All methods used in treating missing data will be 
adequately reported.22 
 
2.6.8 Data Management 
 
Data Sources: Data will be collected prospectively while care progresses and abstracted later 
from patient records. Abstraction will include a review of the ground and air medical 
patient care report(s), emergency department records, and hospital records, both electronic 
and on paper. 
 

 
LITES TO5 (PACT) Protocol v7 02/13/2023 
 
 
14 
 
Data Entry: The DCC will create an electronic data management system that will include a 
password protected SSL website for data entry by participating sites with built in dynamic 
features such as data encryption, user authentication, range and data type checks, real time reports, 
data corrections tracking, and the capability to save and reload incomplete forms.  The DCC will 
also draft a comprehensive data management manual that includes detailed instructions and 
provide training and technical assistance.  Subjects will be identified by a study ID only.  Sites 
will be required to store hard copy source documentation separately in a secured, locked cabinet. 
 
Database Management: A two-tiered database structure will be created. A front-end database 
will serve the needs of web entry at the sites, using a database management system well suited 
to handling updates from multiple interactive users. The data from this database will be 
transferred on a regular schedule to a data repository that can be used by statistical software 
packages. These data sets will be the basis of data queries and monitoring reports. Various 
versions of this database will be kept as needed, such as for quarterly performance reports. 
Access to data will be limited to those who need access to perform their tasks. The database 
management system can manage large quantities of data, merge data from multiple databases 
as required, handle complex and possibly changing relationships, and produce analysis 
datasets that can be imported into a variety of statistical analysis packages.  Data will be 
backed up at regular intervals, with full transaction log files in use, and copies of the data will be 
stored offsite with a secure service.  Servers will be migrated to a new host in the event of a 
hardware failure.  All servers are behind an enterprise firewall and access must be granted through 
the firewall even within the University network. 
 
2.6.9 Data Elements 
 
Prehospital Elements: To include (but not be limited to) scene time, vital signs, times and 
description of prehospital interventions, procedure type(s), device type(s), airway adjuncts 
used, rapid sequence intubation, associated medications and dosages used, number of 
procedure attempts, reason for failed attempt(s), progression to surgical airway, time to 
successful airway management, time to advanced airway, procedure complications, time and 
dose of 
any medications administered (for induction, post intubation sedation, and 
resuscitation), transport time, vital signs during transport, times and description of 
interventions provided during transport, and mode(s) of transport (e.g. ground, air). Also 
includes provider level data—including level of training—and system level data, including 
staffing, service volume, 
frequency of airway management, and ambulance location 
(rural/urban). 
 
In-Hospital Elements: To include (but not be limited to) relevant vital signs, relevant laboratory 
studies (including arterial blood gases), and interventions (especially time to extubation and/or 
reintubation as applicable).  Ventilator associated pneumonia, post- traumatic acute respiratory 
distress syndrome (ARDS), and patient disposition will also be collected. 
 
Outcome Elements: To include (but not be limited to) 24-hour survival, hospital length of stay, 
length of stay in ICU, ventilator days, and in-hospital survival through day 30. 
 
Exploratory Analyses: To include (but not be limited to) associations that may represent the 
underlying mechanisms associated with airway management’s effect on 24-hour survival. When 
the necessary data are available, we will examine time to definitive airway, exposure to hypoxia, 

 
LITES TO5 (PACT) Protocol v7 02/13/2023 
 
 
15 
 
superoxia, hypotension, hypocarbia and hypercarbia. Exposure will be examined as a categorical 
value and as a continuous variable calculated as a function of depth (calculated from a given 
normal value) times duration. The value of this expression will be regressed to look for an 
association with mortality. 
 
2.7 QUALITY CONTROL, ASSURANCE, AND CONFIDENTIALITY 
 
2.7.1 Protocol Compliance 
The participating site investigators will not intentionally deviate from the protocol for any 
reason without prior written approval from the IRB, except in when the safety of the research participant 
is at risk. In that event, the site investigator will notify the IDE Sponsor and the reviewing IRB 
immediately, if possible, and request approval of the protocol deviation. If prospective IDE Sponsor 
and IRB approval is not possible, the site investigator will notify the IDE Sponsor and reviewing IRB 
promptly following the respective protocol deviation. The site investigator will inform the reviewing 
IRB of all protocol deviations and unanticipated events involving risks to the research subjects and 
others and will obtain prospective IRB approval for all proposed protocol changes. Persistent or serious 
noncompliance may result in termination of the site’s participation in the clinical trial. 
 
2.7.2 Protocol Deviations and unexpected problems: 
Successful implementation of the trial will depend on the protocol being carried out as intended. 
Sites will be expected to closely monitor activities at the level of the patient, EMS agency and site, report 
protocol deviations promptly using the electronic data management system, and take necessary actions 
(including retraining), as appropriate, to bring about a resolution and/or prevent a recurrence. The CCC 
and DCC, meanwhile, will be tracking activities at the trial level. Serious deviations will be discussed 
with the other investigators, the DOD, and the FDA to see if the protocol needs to be amended or 
recruitment put on hold. 
 
2.7.3 Privacy and Confidentiality: 
The site investigators and members of their research teams will make a reasonable effort to 
ensure the confidentiality of research subjects. Subjects’ names and other identifiable information will 
be kept in a secure, locked, limited access area separate from the electronic data management system. 
 
2.7.4 Investigator Responsibilities 
The site investigators will agree to implement the IRB approved protocol and to conduct the 
trial in accordance with 21 CFR Part 812, Subpart E, and the ICH GCP Guidelines (E6, Section 5), as 
well as with all applicable national, state and local laws. The trial will be performed in accordance with 
ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH / 
Good Clinical Practice, and with applicable regulatory requirements. 
 
 
3. HUMAN SUBJECTS 
TO 0005 PACT will be conducted under the federal provisions governing Exception from the 
Requirement for Informed Consent for Emergency Research (21 CFR 50.24), including community 
consultation, public notification, and the notification of participants or their legally authorized representative 
as soon as feasible after enrollment. Notification may be through oral and/or written communication and 
will include the opportunity to opt out from ongoing participation. 
Community consultation as determined by the IRB will be undertaken prior to final IRB approval. 
Because the population eligible for enrollment includes all citizens in the trial regions, it will not be possible 

 
LITES TO5 (PACT) Protocol v7 02/13/2023 
 
 
16 
 
to target any particular small group. Feedback from the community regarding any concerns they may have 
about potential enrollment will be obtained by research personnel. Public notification and community 
consultation, as directed by the IRB, may include the use of electronic surveys, ads in local media outlets 
and on public transportation, and/or consultation with community leaders. Due to their ongoing 
participation in numerous multicenter research studies involving emergency research, the institutions 
participating in PACT have significant experience with community consultation and notification practices.   
 
3.1 SUBJECT POPULATION 
TO 0005 PACT will include prehospital patients who are experiencing traumatic injury, require 
advanced airway management, and are receiving care from participating EMS agencies. The trial will 
include only EMS agencies with personnel capable of performing advanced airway management including ETI 
and SGA placement. 
 
3.2 INCLUSION CRITERIA 
1. Traumatic injury requiring advanced airway management. Indicators of the need for advanced 
airway management include: a) GCS < 8, b) SpO2 < 90 despite supplemental oxygen, c) ETCO2 
> 60 despite supplemental ventilation, or d) provider discretion. 
2. Transport (or intended transport) to an enrolling LITES Trauma Center 
 
3.3 EXCLUSION CRITERIA 
1. <15 years of age 
2. Pregnancy 
3. Prisoner 
4. Initial advanced airway attempted by a non-PACT provider 
5. Cardiac arrest without ROSC at time of intervention 
6. Caustic substance ingestion 
7. Airway burns 
8. Objection to study voiced by subject or family member at the scene 
 
Inclusion and exclusion criteria will be assessed based on information available at the time of 
enrollment, defined as the time on scene by the Enrolling EMS Agency.  Although all reasonable efforts 
will be made by the emergency medical crew to either directly witness or obtain documentation of 
eligibility criteria, due to the nature of the emergency prehospital setting, there may be occasions 
where the emergency medical crew must rely on verbal report of eligibility criteria from referring 
hospital or emergency crew. In these instances, if, after subsequent review of outside hospital and/or 
ground crew documentation, it is determined that the subject did not meet eligibility criteria, the subject 
will remain enrolled in the study based on the intention-to-treat principle but the incident will be reported 
as a protocol deviation and the patient will be excluded from the per protocol group for the purpose of 
analysis.  
 
All patients are prospectively enrolled. The interventions, including standard care, are completed prior to 
arrival at the hospital. Any patient not identified as an enrollment at the time of treatment will be a missed 
enrollment. After the interventions are applied, the medical director, who is ultimately responsible for 
enrollment, will confirm the patient met all inclusions and none of the exclusion criteria. A grace period 
of three business days is allowed for clarification of an enrollment for those instances where incomplete 
or conflicting information is provided. If this occurs, documentation in the form of email communication 
or an addendum to the chart by the crew member will be used to clarify the intent of enrollment by the 
EMS clinician.   

 
LITES TO5 (PACT) Protocol v7 02/13/2023 
 
 
17 
 
 
If a verbal report must be used in lieu of physical documentation or directly witnessing eligibility 
criteria, documentation of the verbal report will serve as the source documentation for determining 
eligibility. Verbal reports will be documented outlining the source as well as the details. 
 
 
4. IRB APPROVAL AND FDA AMENDMENTS 
A central IRB at the University of Pittsburgh will be utilized for the regulatory needs of this trial. 
All current LITES Network sites have IRBs that have experience and engagement with central IRB 
procedures. 
The Investigator will obtain from the University of Pittsburgh Institutional Review Board (IRB) 
prospective approval of the clinical protocol and corresponding informed consent form(s) as well as 
modifications to the clinical protocol and corresponding informed consent forms. 
The only circumstance in which a deviation from the current IRB-approved clinical protocol/consent 
form(s) may be initiated in the absence of prospective IRB approval is to eliminate an apparent immediate 
hazard to the research subject(s). In such circumstances, the Investigator will promptly notify the University 
of Pittsburgh IRB of the deviation. 
The University of Pittsburgh IRB operates in compliance with FDA regulations at 21 CFR Parts 50 
and 21 CFR 56, and in conformance with applicable International Conference on Harmonization (ICH) 
Guidelines on Good Clinical Practice (CGP). 
In the event that the University of Pittsburgh IRB requires, as a condition of approval, substantial 
changes to a clinical protocol submitted under an FDA-accepted IDE application, or in the event of the 
Investigator’s decision to modify the previously accepted clinical protocol, the Sponsor will submit (i.e., in 
advance of implementing the change) a Protocol Amendment to the IDE describing any change to the 
protocol that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality 
of the study. 
 
 
5. ENROLLMENT AND INFORMED CONSENT 
PROCEDURES 
5.1 ENROLLMENT METHODS: 
Potentially eligible patients will be identified prospectively by air medical and ground transport 
personnel trained on and familiar with the inclusion and exclusion criteria. The intervention will take place in 
the prehospital environment, performed by personnel trained in prehospital trauma airway management. Those 
who meet all inclusion and no exclusion criteria will be assigned to standard care or initial SGA based on the 
randomization arm currently active for that EMS agency. EMS personnel will notify site personnel of 
enrollments.  Once notified, site personnel will review inclusions and exclusion criteria to verify eligibility and 
report protocol deviations. 
 
There will be some instances where, despite the original intentions of the EMS provider, enrolled subjects will 
ultimately be transported to non-participating hospitals. In these instances, we will retain these subjects as 
enrolled and will notify them of their enrollment into the trial, but we will not anticipate receiving any data 
from their in-hospital encounter. 24-hour mortality may be obtained by searching public records for vital status 
or by other sIRB approved means.  
 
5.2 2 INFORMED CONSENT PROCEDURES 
All guidelines and requirements for notification for exception of consent for emergency research will 

 
LITES TO5 (PACT) Protocol v7 02/13/2023 
 
 
18 
 
be followed. Patients with major trauma who require advanced airway management during or directly 
preceding emergency medical transport are experiencing an immediate life-threatening condition, with the 
patient commonly intubated, unconscious, or not responsive.  In this emergent situation, it will not be possible 
to contact legal representatives at the time of study enrollment. Research coordinators will make every effort 
to contact legal representatives as soon as feasible after admission to the hospital to notify them that the subject 
was enrolled in a randomized trial and to attempt to obtain consent for ongoing data collection. Such 
notification will be in person whenever possible. Summary of these efforts will be documented.  If the subject 
becomes competent during the study period, then he/she will be approached 
by research personnel for 
notification of enrollment and a similar provision of an opportunity to opt out from ongoing data collection. 
The investigators will utilize social workers, law enforcement personnel, or any other available means 
to try to locate the patient's legally authorized representative. If that search is unsuccessful, a notification letter 
will be sent to the subject's authorized representative explaining the study and providing contact information 
for answering questions. The letter will be sent via a traceable method, such as registered mail or by UPS, and 
documentation of the addressee and date of mailing will be kept. 
If the subject expires prior to being notified or obtaining consent, a letter of notification of enrollment 
will be sent to the subject’s representative via a trackable method. This letter will contain important details 
describing the study, as well as provide contact information for the study team and/or the IRB to allow the family 
to ask questions or express concerns with the study. 
If the subject recovers quickly or unexpectedly and is discharged from the hospital prior to the study 
team notifying and obtaining consent, a notification will be mailed to the subject via a trackable method. 
 
 
6. DATA AND SAFETY MONITORING 
 
6.1 DATA SAFETY MONITORING BOARD 
 
A Data and Safety Monitoring Board (DSMB) will be appointed to review TO 005 PACT and to 
provide recommendations about trial continuation to the IDE Sponsor. After initial approval and at periodic 
intervals (to be determined by the committee) during the trial, the DSMB responsibilities are to: 
a. Review the research protocol, informed consent documents, and plans for data and safety 
monitoring. 
b. Evaluate the progress of the trial, including periodic assessments of data quality and 
timeliness, subject enrollment and retention, subject risk versus benefit, adverse events, 
unanticipated problems, performance of the trial sites, and other factors that can affect the 
trial outcome. 
c. Consider relevant external information, such as scientific or therapeutic developments that may 
have an impact on the safety of the subjects or the ethics of the trial. 
d. Review clinical center performance, make recommendations, and assist in the resolution of 
problems reported by the IDE Sponsor or site investigators. 
e. Protect the safety of the trial subjects. 
f. Report on the safety and progress of the trial. 
g. Make recommendations to the IDE Sponsor and, if required, to the FDA concerning 
continuation, termination, or other modifications of the trial based on the observed beneficial 
or adverse effects of the intervention. 
h. Monitor the confidentiality of the trial data and the results of site monitoring  
i. Assist the IDE Sponsor by commenting on any problems with conduct of the trial, enrollment, 
sample size, and/or data collection. 
 

 
LITES TO5 (PACT) Protocol v7 02/13/2023 
 
 
19 
 
The DSMB will include experts in emergency medicine, surgery (trauma / critical medicine), bioethics, and 
biostatistics. DSMB members must be independent of the investigators and have no financial, scientific, or 
other conflict of interest with the trial. Written documentation attesting to the absence of conflict of interest 
will be required. 
 
The University of Pittsburgh Office of Clinical Research, Health Sciences will provide logistical management 
and support for the DSMB. A safety officer (chairperson) will be identified at the first meeting. This person 
will be the contact person for serious adverse event reporting. Procedures for this will be discussed at the first 
meeting. 
The first DSMB meeting will take place before trial initiation to discuss the protocol, approve the 
commencement of the trial, and establish guidelines to monitor the trial. The frequency of further meetings 
will be determined during the first meeting. An emergency meeting of the DSMB will be called at any time 
by the chairperson should questions of subject safety arise. 
 
6.2 DATA SAFETY MONITORING PLAN  
Monitoring of safety and data quality in the proposed study will be the responsibility of all personnel 
on the project, with primary responsibility and supervision by the Investigator. The Institutional Review 
Board will approve the Statement of Informed Consent for the study and provide institutional oversight of 
data and safety issues. The study protocol will be approved prior to enrolling any participants. Moreover, the 
study will be reviewed at a minimum of annual basis (or more frequently as deemed necessary) by the 
IRB committee. Regarding monitoring of data quality and protected health information, all required 
personnel proposed for this project will have the required human subjects and confidentiality training, 
which includes information about maintaining data integrity and security. Confidentiality will be guarded 
using established procedures such as storing source documents containing patient identifiers in locked cabinets 
within locked offices or locked data rooms, using study IDs rather than subject identifiers in the electronic 
data management system, and aggregating data across subjects. The key linking subject names and study 
identification numbers will be kept separately from the data sets with limited access by study personnel. 
Only study personnel will have access to the data sets on protected servers. Oversight of all aspects of data 
management will occur with the DCC. 
 
6.2.1 Parameters to be Monitored 
The following parameters will be monitored by the DSMB throughout the course of the 
research to ensure the safety of subjects as well as the integrity and confidentiality of their data. 
• An evaluation of the progress of the research study, including subject enrollment and retention 
as well as an assessment of the timeliness and quality of the data. 
• A review of collected data (including adverse events, unanticipated problems, and subject 
withdrawals) to determine whether there is a change to the anticipated benefit-to-risk assessment 
of study participation and whether the study should continue as originally designed, should be 
changed, or should be terminated. 
• A review of study procedures designed to protect the privacy of the research subjects and the 
confidentiality of their research data. 
 
6.2.2 Frequency of Monitoring 
The Investigator, sub-investigators, and the research staff will meet regularly to re-evaluate 
study goals, subject recruitment, data coding and retention, documentation and identification of 
adverse events, complaints and confidentiality of subjects. There will be an evaluation of the 
progress of the research study, including assessments of data quality, time lines, participant 
recruitment, accrual, and retention. The Investigator will also review the outcome and adverse event 
data to determine whether there is any change to the anticipated benefit-to-risk ratio of study 

 
LITES TO5 (PACT) Protocol v7 02/13/2023 
 
 
20 
 
participation and whether the study should continue as originally designed or should it be re-evaluated 
and changed. 
 
6.3 REPORTABLE ADVERSE EVENTS 
An adverse event (AE) refers to any untoward medical occurrence caused by, or associated with, the study 
or study device(s). All potential AEs will be documented by the sites using the electronic data management 
system.   All reported adverse events will be reviewed in consideration of the treatment arm and further classified 
by a) Severity (serious or non-serious); and b) Expected or Unexpected. For serious, unexpected adverse events 
felt to be possibly associated with the research intervention, the Coordinating Center will notify the reviewing 
IRB, FDA, DSMB,  and Department of Defense in accordance with requisite reporting time frames. 
Some adverse events are commonly observed in patients following traumatic injury and may or may not be 
attributable to the airway management.  Examples of these include Fat Embolism Syndrome, cardiac arrest, 
myocardial infarction, sepsis, cerebral bleeding, stroke, Deep Vein Thrombosis (DVT), pulmonary embolus, 
rhabdomyolysis, abdominal compartment syndrome, upper gastrointestinal bleeds, HITT, extremity 
compartment syndrome, seizures, surgical interventions, complications due to specific injuries as well as other 
major medical or surgical complications are commonly observed in these patients.   
 Some of these events may be recorded as noted in the medical record however, none of the expected events 
will be reported as adverse events. 
 
6.3.1 Adverse Events Reporting Timeline 
 
A table summarizing reporting timelines is provided below: 
 
Organization 
Fatal/Life 
Threatening 
Reportable 
Adverse 
Event 
Non-fatal, 
non-life 
threatening 
Reportable 
Adverse Event 
Expected 
Adverse 
Events 
Unanticipated 
Problem (not 
involving risk) 
Unanticipated 
Problem 
(involving risk) 
IRB 
24 hours 
10 working 
days 
No 
requirement 
No requirement 
10 working days 
FDA 
7 
calendar 
days 
15 calendar 
days 
No 
requirement 
No requirement 
14 days* 
Dept of Defense 
7 
calendar 
days 
No 
requirement 
No 
requirement 
No requirement 
14 days* 
DSMB 
24 hours 
7 calendar 
days 
No reporting 
At next meeting 
(every 6 
months) 
14 days* 
*Reporting occurs only after an IRB determination of UPIRTSO has been received 
 
6.4 RISKS MANAGEMENT PROCEDURES 
 
6.4.1 Protection Against Risks of Data Collection 
The collection of sensitive information about subjects is limited to the amount necessary 
to achieve the aims of the research, so that no unneeded sensitive information is being collected.  All 

 
LITES TO5 (PACT) Protocol v7 02/13/2023 
 
 
21 
 
demographic and clinical information about the subject will be stored in an electronic password 
protected electronic data management system under the supervision of the DCC for this protocol.  All 
staff involved in this study will be properly credentialed and instructed in the areas of testing, 
confidentiality, and safety. 
The Investigator will retain the data for the entire period of this study and will retain the 
specified records and may continue to use and disclose subjects’ de-identified information for the 
purpose of this study for a minimum of seven years after final reporting or publication of the study. If 
the subject is a minor, records will be retained until his/her age of majority (18 years) and then for 
seven years, at minimum. Subject names or other directly identifiable information will not appear on 
any reports, publications, or other disclosures of clinical study outcomes. 
 
6.5.2 Protection Against Potential Risks of Experimental Intervention 
The investigational devices utilized for this trial are those which are already in use by the 
prehospital providers. All providers have been trained in the proper use of the devices and demonstrate 
competency in accordance with their local protocols and regulations. 
 
 
7. COSTS 
There are no additional costs associated with the research study for the subject, subject’s insurance, or 
enrolling provider.  Enrolling providers are managing the subject’s airway as part of necessary clinical care 
and are utilizing the devices already in supply just as they would normally. 
 
 
8. REFERENCES 
1. Mayglothling J, Duane TM, Gibbs M, et al. Emergency tracheal intubation immediately following 
traumatic injury: an Eastern Association for the Surgery of Trauma practice management guideline. J 
Trauma Acute Care Surg. Nov 2012;73(5 Suppl 4):S333–340. 
2. Wang HE, Cook LJ, Chang CC, Yealy DM, Lave JR. Outcomes after out-of-hospital endotracheal 
intubation errors. Resuscitation. Jan 2009;80(1):50–55. 
3. Wang HE, Mann NC, Mears G, Jacobson K, Yealy DM. Out-of-hospital airway management in the 
United States. Resuscitation. Apr 2011;82(4):378–385. 
4. Bukur M, Kurtovic S, Berry C, et al. Pre-hospital intubation is associated with increased mortality 
after traumatic brain injury. J Surg Res. Sep 2011;170(1):e117–121. 
5. Wang HE, Peitzman AB, Cassidy LD, Adelson PD, Yealy DM. Out-of-hospital endotracheal 
intubation and outcome after traumatic brain injury. Ann Emerg Med. Nov 2004;44(5):439–450. 
6. Wang HE, Kupas DF, Hostler D, Cooney R, Yealy DM, Lave JR. Procedural experience with out-of-
hospital endotracheal intubation. Crit Care Med. Aug 2005;33(8):1718–1721. 
7. Wang HE, Seitz SR, Hostler D, Yealy DM. Defining the learning curve for paramedic student 
endotracheal intubation. Prehosp Emerg Care. Apr-Jun 2005;9(2):156– 162. 
8. Beauchamp G, Phrampus P, Guyette FX. Simulated rescue airway use by laypersons with scripted 
telephonic instruction. Resuscitation. Aug 2009;80(8):925–929. 
9. Hagberg C, Bogomolny Y, Gilmore C, Gibson V, Kaitner M, Khurana S. An evaluation of the insertion 
and function of a new supraglottic airway device, the King LT, during spontaneous ventilation. 
Anesth Analg. Feb 2006;102(2):621– 625. 
10. Leventis C, Chalkias A, Sampanis MA, Foulidou X, Xanthos T. Emergency airway management by 
paramedics: comparison between standard endotracheal intubation, laryngeal mask airway, and I-
gel. Eur J Emerg Med. Oct 2014;21(5):371–373. 

 
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11. Davis DP, Koprowicz KM, Newgard CD, et al. The relationship between out-of- hospital airway 
management and outcome among trauma patients with Glasgow Coma Scale Scores of 8 or less. 
Prehosp Emerg Care. Apr-Jun 2011;15(2):184– 192. 
12. Lairet JR, Bebarta VS, Burns CJ, et al. Prehospital interventions performed in a combat zone: a 
prospective multicenter study of 1,003 combat wounded. J Trauma Acute Care Surg. Aug 
2012;73(2 Suppl 1):S38–42. 
13. Wang HE, Kupas DF, Paris PM, Bates RR, Yealy DM. A multivariate logistic regression model of failed 
prehospital intubation using a prospective, multi-center dataset (abstract). Prehosp Emerg Care. 
2002;6:143. 
14. Larsen MJ, Guyette FX, Suyama J. Comparison of three airway management techniques in a 
simulated tactical setting. Prehosp Emerg Care. Oct-Dec 2010;14(4):510–514. 
15. Ford I, Norrie J. Pragmatic Trials. N Engl J Med. Aug 4 2016;375(5):454–463. 
16. Force ADT, Ranieri VM, Rubenfeld GD, et al. Acute respiratory distress syndrome: the Berlin 
Definition. JAMA. Jun 20 2012;307(23):2526–2533. 
17. Hemming K, Taljaard M. Sample size calculations for stepped wedge and cluster randomised trials: a 
unified approach. J Clin Epidemiol. Jan 2016;69:137–146. 
18. Campbell MK, Elbourne DR, Altman DG, group C. CONSORT statement: extension to cluster 
randomised trials. BMJ. Mar 20 2004;328(7441):702–708. 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix I – Study Sites 
 
*All of the Oregon EMS agencies share training, standard protocols, and clinical competencies.  Furthermore, they 
participate in mutual aid of trauma patients (more than one agency responding to and caring for a single patient).  We 
will step all Oregon EMS agencies at the same time to ensure that patients enrolled in Oregon will have care that is 
consistent with a single randomization unit. 
 
 
  
Site 
EMS Agency 
Participating Trauma Center(s) 
Tulane University 
New Orleans EMS 
University Medical Center 
University of Pittsburgh 
City of Pittsburgh EMS 
UPMC Presbyterian, UPMC Mercy, Allegheny 
General Hospital 
University of Pittsburgh 
STAT MedEvac 
UPMC Presbyterian, UPMC Mercy, UPMC 
Altoona, UPMC Hamot, UPMC Susquehanna, 
Allegheny General Hospital 
University of Pittsburgh 
EmergyCare 
UPMC Hamot 
University of Pittsburgh 
Susquehanna Regional EMS 
UPMC Susquehanna 
Vanderbilt University 
Nashville Fire 
Vanderbilt University Medical Center 
Emory University 
Grady EMS 
Grady Medical Center 
University of Louisville 
Louisville Metro EMS 
University of Louisville Hospital 
University of Louisville 
St. Matthews EMS 
University of Louisville Hospital 
Washington University at St. Louis 
Air Evac Lifeteam 
Barnes-Jewish Hospital 
Washington University at St. Louis 
St. Louis Fire 
Barnes-Jewish Hospital 
East Carolina University 
Vidant EastCare 
Vidant Medical Center 
East Carolina University 
Pitt County EMS 
Vidant Medical Center 
East Carolina University 
Wilson County EMS 
Vidant Medical Center 
East Carolina University 
Lenoir County EMS 
Vidant Medical Center 
Oregon Health & Sciences University 
American Medical Response* 
Oregon Health & Sciences University Hospital 
Oregon Health & Sciences University 
Metro West Ambulance* 
Oregon Health & Sciences University Hospital 
Oregon Health & Sciences University 
Hillsboro Fire* 
Oregon Health & Sciences University Hospital 
Oregon Health & Sciences University 
Molalla Fire* 
Oregon Health & Sciences University Hospital 
Oregon Health & Sciences University 
Canby Fire* 
Oregon Health & Sciences University Hospital 
Oregon Health & Sciences University 
Tualatin Valley Fire & Rescue* 
Oregon Health & Sciences University Hospital 
Oregon Health & Sciences University 
Clackamas Fire District 1* 
Oregon Health & Sciences University Hospital 
Oregon Health & Sciences University 
Lake Oswego EMS* 
Oregon Health & Sciences University Hospital 
Cook County/Chicago 
Chicago Fire Department 
John H. Stroger Jr. Hospital of Cook County 
University of Chicago 
Chicago Fire Department 
UChicago Medicine 
Northwestern University 
Chicago Fire Department 
Northwestern Memorial Hospital 
Mount Sinai 
Chicago Fire Department 
Mount Sinai Hospital 

 
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Appendix II – PACT EFIC PLAN 
 
 
PACT EFIC Plan 
 
Prehospital  Airway Control Trial (PACT) 
Open label, multi-center, stepped wedge cluster randomized trial comparing standard airway management 
strategy and strategy of initial use of SGA for airway management of prehospital trauma patients. 
 
Lead Investigators: 
Jason L. Sperry, MD, MPH 
 
Frank Guyette, MD, MPH 
 
Supported by: 
Department of Defense  

 
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ClinicalTrials.gov ID: 
TBD 
 
 

 
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CONTENTS 
 
INTRODUCTION 
27 
OVERVIEW 
27 
REGULATORY CRITERIA FOR USE OF EFIC 
28 
REGULATORY PROTECTIONS FOR IMPLEMENTING EFIC 
30 
COMMUNITY CONSULTATION PRINCIPLES 
33 
COMMUNITY CONSULTATION MENU 
35 
REPORTING COMMUNITY CONSULTATION RESULTS 
38 
PUBLIC DISCLOSURE PRINCIPLES 
38 
PUBLIC DISCLOSURE MENU - PRE-TRIAL 
39 
PUBLIC DISCLOSURE ACTIVITIES - POST-TRIAL 
41 
REPORTING PUBLIC DISCLOSURE ACTIVITIES 
41 
CONTACTING A LEGALLY AUTHORIZED REPRESENTATIVE (LAR) 
41 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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INTRODUCTION 
The goal of this document is to describe the implementation of the protections associated with 21 CFR 50.24, 
Exception from Informed Consent (EFIC) Requirements for Emergency Research in the PACT clinical trial.  
Implementation of this plan is the first phase of conducting the proposed trial.  The findings acquired from 
planned activities will be presented to the Single IRB (sIRB) to help the sIRB assess community attitudes 
related to the study.  
Research involving the acute care of patients with traumatic injury requiring advanced airway management 
presents ethical challenges. Respecting participants and their autonomy through the informed consent process 
is a cornerstone of ethical research, but patients with traumatic injuries that require airway support are unable 
to participate in an informed consent process. When available, a legally authorized representative (LAR) may 
act as a surrogate decision maker for an incapacitated patient. The LAR can decide if the patient will 
participate in the research study, even though the wishes of the patient may not be known. However, for many 
patients with traumatic injuries, no LAR is readily available during the patient’s resuscitation and emergency 
care.  Excluding patients without capacity or an available LAR from trauma research does not necessarily 
defend patient autonomy since the patient’s actual wishes are unknown.  In fact, when they can be asked, 
patients and their representatives choose to participate more often than not. Excluding patients without 
capacity, however, limits the ability to ever scientifically improve care, and makes enrollment in the emergency 
setting impracticable. Therefore, this study will enroll participants for whom an LAR is unavailable with EFIC.       
OVERVIEW 
All patients meeting eligibility criteria for PACT will generally be obtunded or comatose and unable to give 
informed consent to participate.  Participants will be enrolled in this trial with exception from informed consent 
(EFIC) for emergency research under the conditions established at 21CFR50.24.   
Upon hospital arrival of an eligible subject, study teams will diligently attempt to determine the patient's identity 
and the availability of an LAR.  Attempts will be made to notify an LAR at the earliest opportunity, and consent 
to continue in the study will be sought.   
Enrollment with EFIC 
Upon hospital arrival of an enrolled subject, study teams will diligently try to determine the patient's identity and 
the availability of an LAR.  Both routine hospital and study team resources/processes should contribute to 
these efforts. The steps undertaken to identify the patient and find the LAR should be documented in the 
subject record on an informed consent/contact log.  Once the LAR is available and as soon as it is feasible, the 
LAR will be informed of the subject’s enrollment in the study.  Details of the study, the potential risks, and 
potential benefits of participating in the study will be explained to the LAR.  After discussing the study with the 
LAR, the LAR will be given the option of allowing the subject to continue study participation, or to withdraw 
from further participation the study.  The LAR will be informed that the decision to continue participation in the 
study may be withdrawn at any time throughout the course of the study. If the LAR wants to continue the 
subject’s participation, the LAR will sign the informed consent form.   
The informed consent/contact log is used to document the continuing efforts to locate an LAR, the notification 
of the LAR, the consent process, and the decision of the LAR.  This log will include the types of attempts 
made, the number and times of those attempts, and the outcome of each attempt.  If the subject regains 
decision-making capacity, the patient will be notified of the study and will be asked if he or she wants to 
continue the study.  If no LAR is found and the subject never regains decision-making capacity, the subject will 
remain enrolled under EFIC.  For subjects who expire prior to identification of an LAR, consent is not obtained. 
If an LAR is eventually located, they should be notified of the subject’s participation.  In the rare case where an 
LAR cannot be found and the subject remains incapable of consent at 30 days post admission, attempts to find 
an LAR will be discontinued, but documentation of the LAR search process until that time, and the subject’s 
decisional capacity, will be documented. 
 
Withdrawal from Participation 

 
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An LAR may withdraw the subject from further participation at any time and for any reason.  If the subject 
regains consciousness and decision-making capacity, subjects may also withdraw from further participation.  
Whenever possible, the reason for wishing to withdraw should be determined.  Consistent with OHRP and FDA 
guidance, participant data collected prior to withdrawal from the study is maintained in the study database, but 
no additional participant data will be collected from the participant or their medical record following withdrawal 
from the study.   
REGULATORY CRITERIA FOR USE OF EFIC 
FDA regulations identify the specific circumstances in which EFIC is appropriate.  PACT fulfills these 
requirements for emergency research.  In the following section, the components of the regulation are 
reproduced (in italics), along with an explanation of how PACT will comply with each requirement.  
Traumatic injury requiring advanced airway management is life-threatening and available treatments are 
unsatisfactory or unproven. 
21 CFR 50.24(a)(1) The human subjects are in a life-threatening situation, available 
treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, 
which may include evidence obtained through randomized placebo-controlled 
investigations, is necessary to determine the safety and effectiveness of particular 
interventions. 
Prehospital trauma airway management is a low frequency, high consequence event for both military 
and civilian providers. Airway management failures account for 8-15% of trauma deaths deemed to be 
potentially preventable. Prehospital airway management consists of some combination of basic airway 
maneuvers and bag valve mask (BVM) ventilation to temporize the patient followed by advanced 
management with either an endotracheal tube (ET), supraglottic airway (SGA), or a surgical airway. 
While ET intubation is the gold standard in prehospital airway management, its safety and efficacy have 
been questioned, particularly following trauma and traumatic brain injury. However, other investigators 
have demonstrated associations with survival and ET intubation of trauma patients, resulting in 
equipoise based on existing literature. 
In both civilian and military prehospital environments, acquisition and maintenance of the skills 
necessary for airway management is exceptionally difficult. Previous studies have indicated that 
prehospital providers require ten or more intubations to obtain proficiency at endotracheal intubation 
and approximately between 5-12 per year to maintain proficiency.  Yet the average prehospital provider 
performs <2 interventions per year.  Lairet et al. describe ET intubation as the most frequently missed 
life-saving intervention, accounting for 53% of missed interventions in combat.  The reasons for ET 
intubation failure are complex and include patient, provider, and environmental factors. 
The current alternative used in military airway management is surgical airway (SA). While these 
account for only 1.8% of military prehospital airways, they account for 12% of missed procedures. 
While the success of the procedure is as high as 82%, it is also a rare procedure for which training and 
experience are limited. 
SGAs have been shown to require less time and less practice to achieve proficiency to place.  Although 
older devices performed poorly in military use, newer devices may have several advantages over ET. 
The newer generation of devices have simplified insertion procedures, lack balloons, do not require 
syringes for inflation, and have ports that allow venting and decompression of the stomach. In 
preliminary studies, the I-gel has demonstrated superior first pass success when compared to other 
SGAs. 
In addition to their speed and ease of use, they can be placed blindly without the need for the additional 
equipment necessary for laryngoscopy. In tactical situations, blind insertion techniques may limit 

 
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tactical exposure and improve light discipline.  SGAs have been associated with shorter prehospital 
scene times which may translate into risk reduction for the provider and decreased patient mortality. 
Use of the I-gel may also be a less perishable skill than ET, allowing for better retention and faster pre-
deployment training.  
Obtaining prospective informed consent is not feasible.  
21 CFR 50.24(a)(2) Obtaining informed consent is not feasible because: (i) the subjects 
will not be able to give their informed consent as a result of their medical condition; (ii) 
the intervention under investigation must be administered before consent fr om the 
subjects' legally authorized representatives is feasible; and (iii) There is no reasonable 
way to identify prospectively the individuals likely to become eligible for participation in 
the clinical investigation. 
Potential subjects with traumatic injuries requiring advanced airway management are unconscious and unable 
to provide informed consent due to their medical condition. For patients who require ventilatory support, airway 
management must be initiated rapidly.  There is no therapeutic window available during which an informed 
consent discussion could take place either with the subject or, in the exceedingly rare event that one is present 
at the scene, an LAR. 
In previous EFIC trauma trials conducted at the Clinical Coordinating Center (CCC), the consent for continued 
participation after EFIC enrollment and retention rates were very high.  Since traumatic injury is generally 
accidental and unpredictable, there is no reasonable way to prospectively identify the individuals who will 
become eligible for participation in the research.  
Participation holds prospect of direct benefit to subjects 
21 CFR 50.24(a)(3) Participation in the research holds out the prospect of direct benefit to 
the subjects because: (i) subjects are facing a life-threatening situation that necessitates 
intervention; (ii) appropriate animal and other preclinical studies have been conducted, 
and the information derived from those studies and related evidence support the 
potential for the intervention to provide a direct benefit to the individual subjects; and 
(iii) risks associated with the investigation are reasonable in relation to what is known 
about the medical condition of the potential class of subjects, the risks and benefits of 
standard therapy, if any, and what is known about the risks and benefits of the proposed 
intervention or activity. 
Subjects enrolled in this study are in a life-threatening situation by nature of requiring an airway intervention 
following their trauma. Several preclinical studies have been completed on the topic and two recent RCTs have 
been completed in a prehospital cardiac arrest population demonstrating no difference between the 
interventions (Airways 2) or superiority of the intervention (PART). The risks associated with this study are 
reasonable as both of these methods are standard care for prehospital airway management in 
trauma. Participation in this study offers the potential for direct benefit to the patient through an intervention 
that offers the possibility of reduced mortality associated with airway management in trauma. This study could 
also result in reduced exposure to adverse events such as delayed airway management, hypoxia and 
hypotension. In addition, all providers participating in this study will have reinforced training with respect to 
trauma airway management and mitigation of associated complications all of which may provide direct benefit 
to the patient.  
 
The trial cannot be practicably carried out without exception from informed consent 
21 CFR 50.24(a)(4) The clinical investigation could not practicably be carried out without 
the waiver. 

 
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This research could not be carried out without EFIC because airway management needs to begin rapidly.  
Since trauma patients in need of airway support are unable to consent for themselves and there is rarely a 
LAR available, all subjects will be enrolled under EFIC.  In airway management, time to sufficient ventilation is 
critical.  Inability to obtain informed consent in the absence of EFIC can limit the ability to discover better 
treatments for this critical and life-threatening condition.  
Need for rapid airway management precludes consent from an LAR 
21 CFR 50.24 (a)(5) The proposed investigational plan defines the length of the potential 
therapeutic window based on scientific evidence, and the investigator has committed to 
attempting to contact a legally authorized representative for each subject with in that 
window of time and, if feasible, to asking the legally authorized representative contacted 
for consent within that window rather than proceeding without consent. The investigator 
will summarize efforts made to contact legally authorized representat ives and make this 
information available to the IRB at the time of continuing review.  
The nonexistent therapeutic window described above, the inability of patients requiring airway support to 
communicate, and the lack of an LAR available to provide surrogate consent in almost all subjects precludes 
the possibility of obtaining informed consent for eligible patients in PACT.  Attempts to contact LAR for 
notification and consent to continue participation will be tracked and summarized at continuing reviews if 
requested. 
REGULATORY PROTECTIONS FOR IMPLEMENTING EFIC 
The regulations for EFIC research mandate additional requirements for the implementation of this kind of 
clinical trial.  Each of these additional protections and components of the regulation are reproduced (in italics) 
here, followed by an explanation of how the PACT trial will comply with the requirement.  Further details about 
implementation will follow in a subsequent section.     
Provision of an informed consent document 
21 CFR 50.24(a)(6) The IRB has reviewed and approved informed consent procedures and 
an informed consent document consistent with Sec. 50.25. These procedures and the 
informed consent document are to be used with subjects or their legally authorized 
representatives in situations where use of such procedures and documents is feasible. The 
IRB has reviewed and approved procedures and information to be used when providing an 
opportunity for a family member to object to a subject's participation in the clinical  
investigation consistent with paragraph (a)(7)(v) of this section. 
A written informed consent document for this study will be reviewed and approved by the sIRB.  Subjects 
enrolled in PACT, or their LAR, are approached for consent at the earliest possible opportunity after arrival to 
the trauma center. The study team will be notified of the arrival of all enrolled subjects.  The study team notifies 
the subject or LAR/family about the subject’s enrollment, provides information about the study, the subject’s 
rights, and the responsibilities of the investigators.  The study team answers any questions about the study and 
further participation. A written informed consent document is used to reinforce the information provided in the 
consent discussion, and to document the decision to continue in the study or to not participate any further. A 
copy of this form is provided to the subject. 
Community Consultation 
21 CFR 50.24(a)(7) Additional protections of the rights and welfare of subjects will be 
provided, including, at least: (i) consultation (including, where appropriate, consultation 
carried out by the IRB) with representatives of the communities in which the  clinical 
investigation will be conducted and from which the subjects will be drawn  

 
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The community will be consulted prior to the initiation of research.  The community will be asked to give their 
opinions about the research and the need for EFIC in order to complete this trial.   A detailed menu of 
acceptable options for community consultation is included later in this plan.   The site will choose from this 
menu and perform sufficient consultations to ensure the sIRB that community consultation has been 
satisfactorily completed at each site.  Reporting of community consultation results will be standardized across 
the PACT sites. 
Public Disclosure 
21 CFR 50.24(a)(7) Additional protections of the rights and welfare of subjects will be 
provided, including, at least: ….(ii) Public disclosure to the communities in which the 
clinical investigation will be conducted and from which the subjects will be dra wn, prior 
to initiation of the clinical investigation, of plans for the investigation and its risks and 
expected benefits; (iii) Public disclosure of sufficient information following completion of 
the clinical investigation to apprise the community and researchers of the study, including 
the demographic characteristics of the research population, and its results  
Public disclosure is the primary element in making certain that PACT is conducted in an entirely transparent 
manner. Methods of announcing information about the trial, and the development of advertising and other 
materials about the trial, will take place both locally and nationally. Public disclosure will be initiated prior to 
approval of the trial, may continue during enrollment, and will conclude with dissemination of study results after 
the trial is completed. A menu and discussion of many public disclosure methods and procedures is included 
later in this plan. The sIRB will approve the types and forms of public disclosure.  Reporting of public disclosure 
efforts will be standardized. Summaries of public disclosure will be reported to the sIRB and made publicly 
available. 
Data Monitoring Committee 
21 CFR 50.24(a)(7) Additional protections of the rights and welfare of subjects will be 
provided, including, at least: ….(iv) Establishment of an independent data monitoring 
committee to exercise oversight of the clinical investigation; 
A Data and Safety Monitoring Board (DSMB) will be appointed to review PACT and to provide recommendations 
about trial continuation to the IDE Sponsor. After initial approval and at periodic intervals (to be determined by 
the committee) during the trial, the DSMB responsibilities are to: 
a. Review the research protocol, informed consent documents, and plans for data and safety 
monitoring. 
b. Evaluate the progress of the trial, including periodic assessments of data quality and timeliness, 
participant recruitment, accrual, and retention, participant risk versus benefit, adverse events, 
unanticipated problems, performance of the trial sites, and other factors that can affect the trial 
outcome. 
c. Consider relevant external information, such as scientific or therapeutic developments that may 
have an impact on the safety of the participants or the ethics of the trial. 
d. e. Protect the safety of the trial participants. 
f.  Report on the safety and progress of the trial. 
g. Make recommendations to the IDE Sponsor and, if required, to the FDA concerning 
continuation, termination, or other modifications of the trial based on the observed beneficial 
or adverse effects of the intervention. 
h. Monitor the confidentiality of the trial data and the results of site monitoring. 
i. Assist the IDE Sponsor by commenting on any problems with conduct of the trial, enrollment, 
sample size, and/or data collection. 
 
Contacting Other Family 

 
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21 CFR 50.24(a)(7) Additional protections of the rights and welfare of subjects will be 
provided, including, at least: …. (v) If obtaining informed consent is not feasible and a 
legally authorized representative is not reasonably available, the investigato r has 
committed, if feasible, to attempting to contact within the therapeutic window the 
subject's family member who is not a legally authorized representative, and asking 
whether he or she objects to the subject's participation in the clinical investigati on. The 
investigator will summarize efforts made to contact family members and make this 
information available to the IRB at the time of continuing review.  
EFIC enrollment will not proceed if an LAR or any other surrogate present at the scene remotely declines 
participation on behalf of the potential subject.  However, we anticipate that it will be exceedingly rare that any 
LAR or surrogate will be available at the scene to voice any concern.  As previously noted, there is no available 
therapeutic window during which it would be possible to conduct an informed consent discussion with any 
party, including a non-legally authorized representative. 
Post Enrollment Notification and Consent to Continue 
21 CFR 50.24(b) The IRB is responsible for ensuring that procedures are in place to inform, 
at the earliest feasible opportunity, each subject, or if the subject remains incapacitated, 
a legally authorized representative of the subject, or if such a repres entative is not 
reasonably available, a family member, of the subject's inclusion in the clinical 
investigation, the details of the investigation and other information contained in the 
informed consent document. The IRB shall also ensure that there is a pr ocedure to inform 
the subject, or if the subject remains incapacitated, a legally authorized representative of 
the subject, or if such a representative is not reasonably available, a family member, that 
he or she may discontinue the subject's participation at any time without penalty or loss 
of benefits to which the subject is otherwise entitled. If a legally authorized 
representative or family member is told about the clinical investigation and the subject's 
condition improves, the subject is also to be informed as soon as feasible. If a subject is 
entered into a clinical investigation with waived consent and the subject dies before a 
legally authorized representative or family member can be contacted, information about 
the clinical investigation is to be provided to the subject's legally authorized 
representative or family member, if feasible. 
Subjects enrolled in PACT, or their LAR, are informed of the subject’s inclusion in the clinical investigation at 
the earliest possible opportunity as detailed above.  Attempts to notify the subject or an LAR are repeated until 
successful or until all reasonable efforts and avenues to identify an appropriate LAR are exhausted. All 
notification attempts are logged and recorded in the subject’s research file. Reports of these attempts will be 
available for inclusion in annual reports to the sIRB if requested. 
Record Keeping 
21 CFR 50.24(c) Like other IRB records, records of the determinations above must be kept 
for a minimum of three years after the completion of the clinical investigation. Again, like 
other IRB records, these are subject to inspection and copying by FDA. 
Records documenting the enrollment of participants using EFIC, procedures for notification of enrollment, and 
informed consent forms will be kept for a minimum of seven years after completion of the clinical investigation. 
IDE Requirement 
21 CFR 50.24(d) Protocols involving an exception to the informed consent requirement 
under this section must be performed under a separate investigational new drug 

 
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application (IND) or investigational device exemption (IDE) that clearly identifies such 
protocols as protocols that may include subjects who are unable to consent. The 
submission of those protocols in a separate IND/IDE is required even if an IND for the 
same drug product or an IDE for the same device already exists. Applications for 
investigations under this section may not be submitted as amendments under Secs. 312.30 
or 812.35 of this chapter. 
This trial has been reviewed by FDA, including intent to enroll with EFIC, and the Agency has reviewed and 
provided approval for an IDE for the trial (IDE#G190002). 
Communication of IRB Determination 
21 CFR 50.24(e) If an IRB determines that it cannot approve a clinical investigation 
because the investigation does not meet the criteria in the exception provided under 
paragraph (a) of this section or because of other relevant ethical concerns, the IRB m ust 
document its findings and provide these findings promptly in writing to the clinical 
investigator and to the sponsor of the clinical investigation. The sponsor of the clinical 
investigation must promptly disclose this information to FDA and to the spon sor's clinical 
investigators who are participating or are asked to participate in this or a substantially 
equivalent clinical investigation of the sponsor, and to other IRBs that have been, or are, 
asked to review this or a substantially equivalent investigation by that sponsor. 
PACT will be reviewed and approved by an sIRB.  If the sIRB does not approve the trial, no subjects will be 
enrolled at any site, and all stakeholders will be informed.  Because of an sIRB, there will be no opportunity for 
discordant IRB findings, and no other reporting of disapprovals.   
COMMUNITY CONSULTATION PRINCIPLES 
Implementation of community consultation (CC) in this trial is based on the applicable regulatory language, 
applicable FDA guidance documents (from March 2011, updated April 2013), and the investigators’ own 
empirical ethics research and experience in developing best network practices.   
 
Goals 
The regulatory intent and specific goals of community consultation are not explicit in the regulations and have 
been the subject of academic disagreement.  As described in the FDA guidance, the goals of community 
consultation include: 
● To show respect for persons by informing the community about the study in advance; 
● To inform community members about the trial in advance and provide a means for affected 
communities to provide meaningful input to the IRB before its decision to approve, require 
modifications to, or disapprove the study; 
● To show respect for the community by allowing representatives of the community to identify 
potential community-level concerns and effects of the research; and   
● To show respect for subjects’ autonomy. Respect may be shown by including in community 
consultation activities individuals who may have, or be at risk for, the condition under study (and 
thereby obtain input from a group that is expected to be similar to the eventual study subjects).  
 
This EFIC plan incorporates and interprets these goals into the following specific actionable elements.   
 
To show respect for persons, we suggest CC events that include going out into the community to talk to 
people where they already gather, rather than simply asking them to come to us at events that we originate.  
Showing respect also may involve CC events that specifically engage the investigators responsible for the 
research with the members of the community, rather than only allowing consultations that can be outsourced or 
delegated.   
 

 
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To create effective opportunities for the affected communities to provide meaningful input to the IRB, we 
train for and promote event formats that ensure that study teams listen as much as they talk.  Simply giving a 
presentation about the trial and then asking if there are any questions is not effective CC.  Deliberately brief 
descriptions of the trial, preferably with few or no slides, are followed by probing the community members for 
what additional information is important to them, and by soliciting the values and experiences of the community 
members that are most relevant to the research.  Community members are experts about themselves.  How 
their own narratives intersect with the proposed research and the way in which it will be carried out (under 
EFIC) is the most useful input the community can provide to the IRB. 
 
To show respect for the community, CC activities explicitly reach out both to individuals in the community 
without specific roles, and to representatives of the community.  Representative of the community may be 
religious leaders, community organizers, patient or disease advocates, local political leaders, or others best 
equipped to identify group-level concerns.   
 
Demonstrating respect for the autonomy of a group of individuals who may have, or be at risk for, the 
condition under study is particularly challenging in this population because traumatic injuries can happen to 
anyone.  We meet this goal by asking sites to describe the breadth and depth of the communities they serve, 
and then asking that they complete CC activities that reflect a sufficient portion of that spectrum.     
   
It is also important to explicitly reinforce the FDA guidance by stating the goal of CC is not intended to 
represent community consent.  Consent to participate in research is meaningful only as an individual decision; 
community support of the research does not reflect consent for all members of the entire community.    
Community consultation is therefore not intended to be a form of unbiased voting, deliberative democracy, or 
other purely quantitative activity, but rather an opportunity for open discussion and commentary.  The IRB 
makes the final determination on study approval based on information obtained from the community 
consultation.  
 
Definition of Community 
For the purposes of EFIC, the definition of community includes “the community in which research will take 
place” and the “community from which subjects will be drawn.”  In other words, the community includes the 
geographical area from which patients will be drawn and the group of patients with, or at risk for, the disease of 
interest.  Communities have many subgroups that can be defined by innumerable characteristics such as race, 
ethnicity, religion, age, gender, wealth, education, employment, neighborhood and other factors.  Community 
consultation should consider the heterogeneity of the community and seek diverse input.  It is understood, 
however, that it is impracticable to reach every possible subgroup, but each site will complete activities that 
reflect a sufficient portion of the spectrum of their relevant communities.    
 
Content 
The content of community consultation will inform the community participants that informed consent will not be 
obtained prior to enrollment in the trial.  Informational materials developed for PACT community consultation 
activities are included in the appendix of this plan and are subject to sIRB approval.  Additional materials 
developed later will be submitted to the sIRB for approval before being used in any CC/PD activities.  
Specifically, the content of all CC activities will: 
● Tell the community about the most relevant aspects of the trial including its potential risks and potential 
benefits, and the lack of any therapeutic window  
● Hear the perspective of the community on the proposed research, elicit values and experiences 
 
 
Types of Events 
Based on our interpretation of the regulations and their proposed ethical basis, we have prepared a menu of 
the types of events and activities that PACT sites may use to meet their requirements for CC.  Sites will 
prepare a site plan that lists all the events and activities that they will use to engage the community.  Each site 
plan will:  
● Provide opportunities for broad community discussion 

 
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● Ensure that representatives from relevant communities participate in the consultation process 
● Include more than one type of event or activity to provide for effective community consultation 
● Consider multiple factors including, but not limited to, the size of the communities, the languages 
spoken within those communities, the heterogeneity of the population 
COMMUNITY CONSULTATION MENU 
A (Optional) 
B (Required) 
A presentation and discussion by an investigator visiting 
a meeting of an existing group (visits to existing 
meetings)  
Web-based survey (provided by 
coordinating center) 
Focus group (moderated small group session) 
In-person solicited survey e.g. waiting room 
(template provided by coordinating center) 
In-person individual interviews or meetings  
 
A booth or table at community events involving 
interactive discussions (not just surveys) 
 
Meetings convened by the investigators inviting the 
targeted audience (preferably with RSVP) 
 
Social media messaging 
 
 
Required mix is at least 4 total CC events or activities.  Among these 4 events or activities must be those 
provided in column B and at least 2 events or activities must be of a type in column A.  The 2 events of a type 
in column A may be of the same type, for example, they could both be focus groups or visits to existing groups.  
Events should include participants representing a sufficient breadth of the diversity of the geographic 
community primarily served by the enrolling sites’ institution.  There is no expectation that all of the subgroups 
of a community can be engaged.   
 
 
Visits to existing meetings or existing groups 
In this method of community consultation, members of the study team, sometimes accompanied by 
representatives of their participating institutional research leadership, ask to present the study and lead a 
discussion about the study at a regularly scheduled meeting of a relevant community group.  Sometimes, the 
existing group may hold a special meeting for this purpose, but the study team still goes to the group (rather 
than asking members of the group to come to the study team).   
 
Existing groups that might be consulted using this method may include, but are not limited to: trauma-related 
support or interest groups, civic groups, neighborhood groups, service organizations, athletic groups (inclusive 
of athletes, coaches, and trainers at any level of competition from high school to professional), parent-teacher 
associations, faith-based organizations, political or governmental bodies, business groups, social clubs, retiree 
groups, and college fraternities or others.  Examples of governmental bodies include law enforcement and fire 
and EMS department groups, city councils, and community boards.  This approach may also include study 
team visits to senior centers or rehabilitation facilities.  Participation in an existing meeting shows respect for 
community by bringing the information to the community, reduces inconvenience to the community, and 
exposes the study to a diverse audience.  Community members may be more comfortable expressing their 
opinions in a known setting.  Investigators may have to travel, attend multiple meetings, and conform to the 
community group’s schedule.  Using this method can encourage more involvement by co-investigators and 
other members of the study team, which can be advantageous. 
 
Prior to and during the visit, the study team must clearly communicate that being allowed to attend the meeting 

 
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does not imply any implicit approval or endorsement by the group being visited. 
 
Best Practices: 
● An investigator or study team member should be present to take and answer questions from the 
community. 
● Presentation should be brief (i.e., 10 to 15 minutes). 
● If a presentation is longer than 15 minutes, it should be interactive throughout the presentation. 
● The presenter should be knowledgeable about the study and comfortable with the group.  
● Allow ample time for community discussion (at least 15-30 minutes). 
● Often best to ask for 30 minutes on an existing meeting agenda to allow 10 minutes to present, 15 
minutes for discussion, and 5 minutes to hand-out and get back evaluation surveys.  Insufficient time 
for solicitation of feedback greatly reduces the utility of this method. 
● Probe for discussion using open-end questions.  Ask participants about their experiences and what 
they care about. 
● Ensure that the discussion includes feedback from the participants on EFIC. 
● Light refreshments may be sponsored, direct monetary incentives are uncommon. 
● An anonymous survey for group participants to indicate their thoughts, feelings, and opinions about the 
EFIC regulations and the study is typically collected at the end of the event. 
 
Focus groups 
In this approach, a trained facilitator interviews and moderates a discussion in several small groups (generally 
about 8 to 12 participants).  This method can be conducted with or without an investigator present, but the 
former is favored.  Unlike focus groups designed for other research purposes, these focus groups are 
performed as community consultations.  They are an opportunity for investigators to directly listen to 
community members, and to show their respect by listening humbly.  An investigator may often start the 
session by briefly presenting information about the trial or may elect to allow the facilitator to proceed and listen 
and be available to clarify issues and answer questions.  The facilitator runs the discussion using an explicit 
guide prepared by or reviewed beforehand by the investigative team. The facilitator elicits the group’s views, 
questions, concerns and comments about the study.  The interaction is generally audio-taped (and possibly 
videotaped) for review by the investigative team and the facilitator to allow subsequent analysis and reporting 
of the session.  Focus groups could solicit feedback from any relevant focus of the community, including: the 
general public, individuals affiliated with particular organizations or subgroups, or specific patient populations.   
 
Recruitment methods for focus group participants will depend on the targeted population.  Participants may be 
recruited by mail or telephone, at random from volunteer banks or public data sets, or from special populations 
(such as patients with prior traumatic injury or their families, advocacy group representatives or other vested 
interest groups).   
 
Compared to other methods of community consultation, focus groups may allow for more in-depth discussion 
of the study because of their small size.  They also allow for interaction not only between the facilitator and 
participant but between participants.  For these reasons, focus groups offer a rich set of information and have 
often been found by investigators and IRB members to be a high-quality source of information.   
 
Best Practices: 
● The meeting should be at an accessible location and time for the population included. 
● The session should generally be run by a trained facilitator; sometimes it is helpful if it is someone who 
is also demographically concordant with the focus group participants (experience, race, ethnicity, or 
gender). 
● Sessions should be small, generally including 8 -12 participants. 
● Focus groups generally run 1 to 2 hours in length. 
● Refreshments should be provided. 
● Participants are generally paid for participation in focus group sessions in an amount and form 
appropriate to the participant population. 

 
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● An anonymous written survey for group participants to indicate their thoughts, feelings, and opinions 
about the study and the focus group session should be conducted at the end of the event.  
 
Convened (invited) meeting 
Sometimes called a “Town Hall Meeting”, this type of CC uses the same structure and best practices as visits 
to regularly scheduled meeting but invites a target audience to a meeting convened by the study team.  The 
potential advantage of this method is that multiple groups of attendees can be invited to the meeting and have 
a chance to interact with each other and the investigator.  Because the meetings are typically open to the 
public, there is the potential to involve everyone.  The disadvantage with this method is that organizing such a 
meeting and attaining adequate attendance can be burdensome and difficult.  To be successful, however, an 
intensive effort to diligently invite several potential attendees and secure their commitment to participate is 
needed.  Merely advertising a public meeting and seeing who shows up leads to events with very few 
community members.  Such low attendance events have been commonly held in prior EFIC trials but are not 
acceptable for PACT.  The use of invited meetings, therefore, is discouraged unless the site has a track record 
of successfully using this method in the past. 
 
Community events - interactive or survey 
In this type of event, the study team and investigator typically set up a booth or table at an existing community 
event and interact with individuals one at a time as they browse or stop by the booth.  Events of this kind have 
occurred at State Fairs, Fire and Emergency Services Open Houses, Farmers Markets, Art Festivals, Music 
Concerts, Health Fairs, Ice Cream Socials, Disease-related Fundraising Events, Tailgates and other Sporting 
Events.  This kind of event often allows exposure to a large number of community members.  Depending on 
the kind of event, it may allow investigators to reach a focused or very diverse group and a large number of 
participants.  Because conversations are typically one on one, this method often allows more intimate and 
revealing opportunities for the investigator and members of the public to interact.  The disadvantage of this 
approach is that most of the contacts are very brief, usually limiting the opportunity to exchange information.  
Also, the time commitment from the study team to staff the booth for the duration of the event may be 
significant, making this potentially inefficient.  This type of event can be conducted in a way that is more 
interactive, in which an investigator or other study team member primarily engages participants in 
conversations, often concluding with having the participant fill out a survey either through an interview or by 
completing a written tool.  The event can also be conducted in a way that is primarily driven by just giving out 
written information about the study and asking participants to fill out a written survey.  In this case, the booth 
can be staffed without an investigator present, which can be more efficient for the study team.   
 
Best Practices: 
● Booths should have good signage that attracts passers-by.   
● Have small treats or “swag” to attract participants and thank them for taking time to talk to you. 
● Have enough staff at the booth to engage with anyone who wants to talk. 
● Have enough clipboards and pens to make certain no one has to wait to complete written feedback. 
● It is often effective to make this kind of event a fun social team-building exercise for the study team.   
 
Telephone (random digit dialing) survey  
Large telephone surveys can provide the most statistically representative description of community responses 
to questions about the study and EFIC.  This approach also has the potential to access the views of members 
of the community that are unlikely to attend other types of community consultation activities.  Interviewers 
should be trained by the study team about PACT.  Telephone surveyors are trained to read information 
verbatim provided to them by the study team about the study and EFIC.  They then ask close-ended questions 
and solicit open-ended comments and questions.  This information is then summarized and reported back to 
the investigators and the sIRB.  It is important that the survey and accompanying guide used by the 
interviewers should be carefully written and tested by the study team.  Vendors can potentially perform large 
online surveys that are akin to these large random digit dialing surveys. 
 
There are several limitations to this method.  Telephone surveys can be intrusive and unwelcomed.  Also, 

 
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because they are delegated rather than conducted directly by the investigators, they do not allow investigators 
to demonstrate the same level of interpersonal respect for persons or communities as other methods.  
Questions are typically narrow and closed ended in this approach.  Professional surveyors are also not 
generally equipped to answer clarifying questions about the trial or EFIC.  To achieve a reasonable sample 
size, telephone surveys have to be short.  The presentation of EFIC and PACT is therefore necessarily very 
limited, so responses may not be as well informed or may be less reflective than responses solicited in more 
interactive methods.  The extent to which this method produces systematically different responses is unknown.   
 
Simple solicited surveys like those performed online, in waiting rooms, or at booths 
Simple individual surveys, whether performed on-line or in person, can also be used to solicit community 
questions and views.  This method can be used to reach large numbers and a wide variety of respondents.  
Online surveys can be linked to social media platforms or can be easily solicited by email.  Respondents can 
also be recruited to complete surveys distributed in-person in relevant clinical settings like emergency 
department or clinic waiting rooms.  These simple survey methods can potentially provide more background 
information and are much less expensive.  Internet and paper surveys also allow respondents to see visual 
aids and diagrams not possible with telephone surveys.  Waiting room surveys may allow focus on populations 
with particular health care or traumatic injury experience.  Online and waiting room surveys otherwise have the 
same limitations as telephone surveys.  Careful writing and testing of surveys remains critically important. If 
surveys are distributed in person, surveyors need to be well trained in the study protocol and in the EFIC 
regulations. 
 
Best Practices: 
Whenever possible, these surveys should be conducted by members of the study team, and/or delegated 
surveyors with medical knowledge and training in the protocol and EFIC. Medical students and residents can 
sometimes be recruited as surrogates for the investigative team. 
 
Other social media 
Social media offers a low cost, potentially far reaching, and potentially interactive method to exchange 
information with members of a community.  Recent data suggest that the penetrance of social media is very 
high with 80% of adults in the US accessing Facebook, Youtube, Instagram, Pinterest, Snapchat, LInkedin, 
Twitter, or WhatsApp daily (while only 29% read print newspapers daily).  Social media may also allow 
messages to be directed to selected subgroups and demographics.  Also, different platforms are favored by 
different demographics. Social media is a medium that blurs the line between one-way communication (as 
used in public disclosure) and dialog (as used in community consultation).  The former type of use is probably 
more common, but truly interactive social media communications are also possible.  If chosen as a CC activity, 
the content of the presentation, the methods to allow interaction, and gaps in the available population should 
be clearly described. 
REPORTING COMMUNITY CONSULTATION RESULTS 
All community consultation activities must be reported to the CCC.  Study site personnel will send 
their aggregate data of their community consultation activities, by event.  Data required includes:  
information about the participants, the presentation, participant questions and comments, and 
responses to closed- and open-ended survey questions.  The results will be further collated to 
produce individual site or trial-level reports.    
PUBLIC DISCLOSURE PRINCIPLES 
Public disclosure (PD) is defined in guidances as the “dissemination of information about the research 
sufficient to allow a reasonable assumption that communities are aware of the plans for the investigation, its 
risks and expected benefits and the fact that the study will be conducted”. It also includes “dissemination of 
information after the investigation is completed so that communities and scientific researchers are aware of the 
study’s results.”   
 
Goals 
The regulatory intent and specific goals of PD are not explicit in the regulations and have been the subject of 

 
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academic disagreement.  This plan is based on the presumption that the primary goal of public disclosure is 
transparency.   
 
Transparency is achieved when information about the study is broadly and publicly disseminated through 
multiple channels.  We note that transparency has a protective effect because investigators will not propose 
anything that they would not be willing to announce and defend openly.  
 
Adequacy of public disclosure and transparency is best measured like advertising, by the size of the potential 
audience of the disclosure, rather than by knowledge or recollection of the audience.  In fact, the more benign 
and acceptable the content of a public disclosure is, the less likely it will be internalized and recalled.   
  
Content 
The content of PD materials will vary with the media used.  Advertisements (whether signs, print media, 
broadcast, or electronic) may have limited space.  These disclosures may convey short messages and how the 
audience can obtain more detail.  Follow up examples may include ways to talk to the study team, or a link to 
the study website.  Short messages should at a minimum emphasize: 
● That a research study of patients with traumatic injury that require airway support is being conducted 
locally. 
● That the study will enroll patients with injuries that prevent them from participating in informed consent. 
● Who to contact or where to find additional information. 
 
Other forms of disclosure, such as press releases, websites, or brochures for example, allow for greater detail 
and should, depending on available space, also include: 
● Information about airway management and how it is performed 
● The purpose of the research 
● Who will be included in the study 
● A description of the two treatment strategies being compared 
● A balanced description of the potential clinical and research risks and benefits 
● Synopsis of the research protocol and study design 
● Participating sites/institutions 
● Description of the attempts to contact a LAR 
 
After the clinical trial is completed, further public disclosure should include: 
● The findings of the trial 
● Impact of what was learned on patient care 
● Where to find resources for further information 
● Gratitude and thanks to the study subjects, their families, and their communities. 
 
PUBLIC DISCLOSURE MENU - PRE-TRIAL 
A (Optional) 
B (Required) 
Paid online advertisements (banner, block, or video ads 
purchased from Google, Facebook, Youtube, etc.) 
National or local study website 
(provided by the coordinating center) 
Social media/internet postings (Youtube, Facebook, Twitter, 
etc.) 
Press release (template provided by 
CC) 
Mailings (including email circulars/bursts and direct paper 
mailings) 
 
Booth/Table Community event 
 

 
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Outdoor advertising (placards, bus ads, billboards, etc.) 
 
Television and radio ads (broadcast advertising) 
 
Newspaper advertisement (and similar print advertising) 
 
News stories, interviews (print, radio, or TV) 
 
Newsletters (articles or informational ads, print or 
electronic) 
 
Brochures, flyers, handouts, bulletin boards 
 
Radio or TV PSA (public service announcements) 
 
 
Several different channels of PD should be used.  This will increase the depth and breadth of market 
penetration.  The required mix is at least 4 total PD activities, including at least 2 of a type in column A, and 
both types in column B.  Distribution of activities should be cognizant of the anticipated audiences and should 
include audiences representing a sufficient breadth of the diversity of both the geographic community primarily 
served by the enrollment site, and the community either at-risk for, or familiar with, traumatic injury.  There is 
no expectation that all potential audiences will be reached.  It is expected that PD efforts will represent a good 
faith effort to provide transparency across the relevant communities. 
 
Networking 
Electronic platforms can provide a passive or interactive approach to disseminating information that has 
benefits and challenges.  Measurement of the audience reached by these methods may be elusive.  Access 
may be limited to those segments of the population with regular computer access, although internet access 
through cell phones is rapidly becoming common in all parts of society.  Despite these minor concerns, 
electronic social media and other e-platforms are inexpensive to develop, are wide-reaching and can be 
relatively democratic, and can even permit continuous and anonymous input from the public.  Hospitals and 
community-based organizations often host and curate websites, social media accounts (Facebook, Twitter, 
etc) and listservs, that can be efficiently leveraged to disseminate a message broadly.  
 
Paid advertising 
Purchased advertising in broadcast and print media ensures dissemination of accurate materials to a wide 
audience. Advertisement of the study may occur on a major news radio station serving the area surrounding 
the study hospitals.  A 30 to 60 second sound bite should include a general description of the study, the 
website address, and contact information where more information can be provided if desired.  Printed 
materials, including advertisements for publication in newspapers and magazines, brochures, and flyers, will 
be provided by the CCC.  Advertisements should be placed in both English language and foreign language 
newspapers as appropriate to the local community.  Printed advertisements should provide a general 
description of the study, the national and/or local website address, as well as site contact information. 
 
Conventional informational outlets 
Press releases leading to newspaper and periodical articles are an effective form of public dissemination.  
Investigator appearances on local news, radio or television call-in talk shows can accomplish both public 
disclosure and community consultation.  In addition to traditional news outlets, it is often possible to obtain 
coverage in local health focused newsletters, in direct mail advertisements and educational materials sent out 
by health care organizations and in newsletters of traumatic injury advocacy and support groups.  A video on 
the proposed study will be available for use in public service announcements and for dissemination to media 
outlets.  Local community access cable stations may be accessible to investigators.  Cable access channels 
may offer appearances on shows presenting issues of local interest or may offer to broadcast prepared 
materials. 
 

 
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Brochures and flyers may be disseminated in locations including: 
● Medical sites (e.g., emergency department waiting rooms, medical clinics, dentist offices, etc.) 
● Health fairs (community, employer, school, etc.) 
● Support groups and other existing community groups 
● Schools, universities,  
● Churches and other religious affiliates 
● Grocery & laundry-mat bulletin boards 
● Through large employers (i.e., hospitals, universities, etc.) 
 
Local flyers and brochures distributed should reference the study website as an additional resource for 
patients, families, and healthcare providers to get information as well as ask questions about PACT.   
PUBLIC DISCLOSURE ACTIVITIES - POST-TRIAL  
Post-trial public disclosure activities may include any of the methods used pre-trial, especially press releases 
because results of trials can be especially newsworthy.  Post-trial public disclosure also includes a number of 
more specific additional methods.  Post-trial disclosure includes publication of the trial results in a major 
scientific journal and presentation of the results at scientific meetings.  Through these publications and 
presentations, it usually possible to leverage the existing public relations machinery of the journals and the 
meeting to amplify the message through broader media outlets as well.  
REPORTING PUBLIC DISCLOSURE ACTIVITIES 
All public disclosure activities must be reported to the CCC.  Study site personnel will provide data on each 
activity including:  name and type of activity, size of anticipated audience, and characteristics of the intended 
audience, and timing and duration when relevant.  Activity data will be further collated to produce individual site 
or trial-level reports.    
CONTACTING A LEGALLY AUTHORIZED REPRESENTATIVE (LAR) 
The definition and hierarchy of LAR is determined by local state regulations.  
 
When more than one LAR are present, the LAR highest in the local hierarchy should give consent. However, 
unless otherwise stated in local or state regulations, any LAR may consent if others are not promptly available.  
 
EFIC does not obviate the need to seek patient or LAR consent to continue participation after EFIC enrollment. 
Potential subjects are also not enrolled under EFIC if any family objects to enrollment at the scene, even if they 
are not an LAR.  Subjects enrolled in PACT, or their LAR or family, are informed of the subject’s inclusion in 
the clinical investigation at the earliest feasible opportunity.  The subject (or LAR or family) is approached, and 
an informed consent process initiated, as soon as possible. 
   
LAR identification and tracking will typically be a shared responsibility between the onsite social workers (or 
equivalent) and the study team. The site team should review the local protocol for an LAR search and assure 
that it is sufficient (multiple methods for locating LAR and multiple attempts), and if not, recommend additional 
steps be put in place. 
 
Once available after an EFIC enrollment, an LAR will be informed of the patient’s enrollment into the study and 
of the study details and potential risks and potential benefits of study participation.  At that time, the LAR will be 
given the option to continue participation in the study, or to cease participation then or at any time throughout 
the course of the study. If the LAR wants to continue participation, an informed consent process is performed 
and an informed consent form signed by the LAR will be obtained. If an established LAR has given consent for 
the participant to continue, other family members' objections to inclusion will not result in the participant's 
removal from the study.  If the participant regains decision making capacity, the participant will be asked to 
consent to or decline continued participation in the study.  If the participant wishes to continue, the participant 
will sign an informed consent form. 
 
The study team will document efforts to find the LAR.  This will include contact person (Subject, LAR, Other), 
number of attempts, date and time and outcome of attempts. The tracking process should continue until 

 
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consent or withdrawal is obtained or notification of enrollment is provided. The tracking process is complete 
once one of the following has occurred:  
• 
the LAR or subject has provided consent, 
• 
the LAR or subject has withdrawn, 
• 
the subject has expired and LAR has been notified of study inclusion,  
• 
a period of at least 30 days has passed without subject regaining capacity and all attempts to identify an LAR 
have failed. 
 
For participants who expire prior to identifying an LAR or before LAR consent is obtained, consent should not 
be pursued further. However, once an LAR is located, they should be informed of the subject’s participation.  
The study team should document the notification conversation.  If it is not possible to have this notification 
conversation with the LAR or family of a deceased subject in the hospital, a “family notification letter for a 
deceased subject’’ should be used to notify the LAR or other family.  A copy of the family notification letter (with 
return receipt) should be kept with the study documents. 
 
In the rare case where no LAR consent is obtained, the LAR is never available, and the participant remains 
incapable of consent at six months, documentation of the attempt process and condition of the participant will 
be recorded.