Conditions: Cardiopulmonary Arrest Respiratory Arrest
Keywords: etomidate ketamine endotracheal intubation anesthesia induction medications
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 801
Healthy volunteers: no

Brief summary:
Patients who are having problems breathing sometimes require placement of a breathing tube in their mouth and windpipe. The purpose of this breathing tube is to save the patient's life. It is common to give the patient a medication to sedate him or her before the breathing tube is placed. For patients who are gravely ill two medications are commonly used: etomidate or ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical Center and Parkland Memorial Hospital would like to do a study to figure out which one is better for our patients.

Detailed description:
Critically ill individuals who require emergency endotracheal intubation (placement of a breathing tube in the patient's mouth) usually require sedation or anesthesia to make this process tolerable. There are several medication choices for anesthesia, including medications like etomidate, ketamine and propofol. Of these, etomidate and ketamine are frequently used for critically ill patients because they have minimal effects on the patient's vital signs (blood pressure and heart rate). Both etomidate and ketamine are standard-of-care medications, locally and nationally, and both are frequently used to sedate a patient for this procedure. Both etomidate and ketamine have potential side effects. One of the potential side effects of etomidate is suppression of adrenal gland function. It is not known if this affects patients' outcomes in significant ways. One of the potential side effects of ketamine is a slight increase in patients' heart rates. It is not known if this affects patients' outcomes in significant ways.

The EvK Trial will be conducted at Parkland Memorial Hospital by investigators in the Departments of Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, Surgery, and Pharmacy. The study will randomize critically ill patients who require emergency endotracheal intubation to one of two groups: Etomidate or Ketamine. We will observe the patients' outcomes. The only study intervention involves randomizing individual patients to one medication or the other. All study follow-up beyond that point is done by review of medical records.

Because of the nature of this study - an emergency procedure on a critically ill patient - the study will require institutional review board permission not to obtain written informed consent from the patient prior to randomization of study drug for administration for endotracheal tube placement. Prior to enrollment of patients the study team will carry out a comprehensive Community Consultation Plan, which is designed to inform the community about the research study. This is in accordance with rules set forth by the U.S. Food and Drug Administration (FDA 21 CFR 50.24).

Arms:
arm 1: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. arm 2: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.

Interventions: intervention 1: Etomidate intervention 2: Ketamine intervention 3: Emergency Endotracheal Intubation intervention 4: Mechanical Ventilation
Intervention descriptions: intervention 1: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation. intervention 2: Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation. intervention 3: Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes. intervention 4: Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.

Protocol document:
Prot_SAP_001.pdf: 
 
Official title: Etomidate versus ketamine for emergency endotracheal 
           intubation: a prospective randomized clinical trial 
 
NCT number: NCT02643381 
IRB Approval date:  December 30, 2016 


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Etomidate versus ketamine for emergency endotracheal intubation: a 
prospective randomized clinical trial 
 
Short Title: The EvK Trial 
 
Departments of Anesthesiology, Emergency Medicine, Internal Medicine, Surgery and Pharmacy 
at Parkland Memorial Hospital  
 
Principal Investigator 
 
Gerald Matchett, MD 
UT-Southwestern Dept. of Anesthesiology 
5323 Harry Hines Blvd, MC 9068 
Dallas, TX 75390-9068 
 
Co-Investigators 
Michael Cripps, MD 
Shaina Drummond, MD 
Alexander Eastman, MD 
Brian Farrell, CRNA 
Pamela Fox, CRNA 
Irina Gasanova, MD 
Tjasa Hranjec, MD 
Ahamed Idris, MD 
Girish Joshi, MD 
Simon Lee, Ph.D 
Matthew Leveno, MD 
Abu Taher Minhajuddin, Ph.D 
Christian Minshall, MD 
Tiffany Moon, MD 
Dawood Nasir, MD 
Babatunde Ogunnaike, MD 
John Pease, MD 
John Pennant, MD 
Mary (Christi) Sunna, CRNA 
William Tongier, MD 
 
Technical Consulting 
Timothy J. Ryan, Ph.D 
 
 
 
 
 
 
 


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Contents 
Principal Investigator and Co-Investigators   
 
 
 
 
1 
Plain Language Summary 
 
 
 
 
 
 
 
3 
Introduction and Purpose  
 
 
 
 
 
 
 
3 
Detailed Background, Evaluation of Prior Research and Internal QA/QI Data 
4 
Concise Summary of Project  
 
 
 
 
 
 
6 
Study Procedures  
 
 
 
 
 
 
 
 
7 
Sub-Study Procedures  
 
 
 
 
 
 
 
9 
Criteria for Inclusion of Subjects 
 
 
 
 
 
 
9 
Criteria for Exclusion of Subjects 
 
 
 
 
 
 
9 
Sources of Research Material  
 
 
 
 
 
 
9 
Recruitment Methods and Consenting Process 
 
 
 
 
10 
Potential Risks 
 
 
 
 
 
 
 
 
11 
Subject Safety and Data Monitoring  
 
 
 
 
 
12 
Procedures to Maintain Confidentiality 
 
 
 
 
 
12 
Potential Benefits 
 
 
 
 
 
 
 
 
14 
Biostatistics 
 
 
 
 
 
 
 
 
 
15 
Literature References  
 
 
 
 
 
 
 
16 
Figure 1: QA/QI Data: Monthly Intubations by Anesthesia Code Team 
 
19 
Figure 2: QA/QI Data: Historical Drug Selection 
 
 
 
 
20 
Figure 3: QA/QI Data: Survival Curves 
 
 
 
 
 
21 
Figure 4: QA/QI Data: SOFA Scores  
 
 
 
 
 
22 
Figure 5: Proposed Study Workflow  
 
 
 
 
 
23 
Appendix 1: Primary and Secondary Endpoints 
 
 
 
 
24 
Appendix 2: Study Liaison Assignments 
 
 
 
 
 
25 
Appendix 3: Sample Data Collection Form  
 
 
 
 
27 
Appendix 4: Draft Study Worksheet  
 
 
 
 
 
28 
Appendix 5: Community Consultation Plan and Enrollment Notification Plan 
29 
Appendix 6: Provisional Timeline of CCP Outreach Events  
 
 
45 
Appendix 7: Graphical Description of Approximate Timing of Outreach Events 
46 
Appendix 8: List of Community Leaders for Community Consultation 
 
47 
Appendix 9: Draft Outreach Letter to Community Leaders  
 
 
61 
Appendix 10: Draft EvK Trial Website 
 
 
 
 
 
62  
Appendix 11: Draft Print Advertisements  
 
 
 
 
 
65  
Appendix 12: Draft Poster / Flyer Advertisement 
 
 
 
 
66 
Appendix 13: Draft Notice of Study Enrollment Letter, to Patient  
 
67 
Appendix 14: Draft Notice of Study Enrollment Letter, to Family / Next-of-Kin 
68 
 
 
 
 
 
 
 
 
 


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1. Plain Language Summary 
Patients who are critically ill may require emergency placement of a breathing tube in 
their mouth and windpipe. The purpose of this breathing tube is to save the patient’s life. Usually 
the treating medical team administers a drug to sedate the patient before the breathing tube is 
placed. For critically ill patients it is common to choose either etomidate or ketamine to sedate 
the patient. These drugs are often chosen because they have few effects on the patient’s blood 
pressure and heart rate. Etomidate has some other serious side effects which include interference 
with the production of steroids by the adrenal glands. Previous studies have suggested that 
etomidate may cause greater long-term illness and even death because of this side effect. The 
purpose of the EvK Trial is to evaluate which drug (etomidate or ketamine) is better for patients 
who are critically ill. We believe that ketamine is associated with improved chance of survival 
after emergency endotracheal intubation because it does not interfere with steroid production. 
Because this study involves research of an emergency medical procedure, we have created a 
comprehensive Community Consultation Plan and Post-Enrollment Notification Plan that meets 
U.S. Food and Drug Administration regulations for emergency research. 
2. Introduction and Purpose: 
Patients who are critically ill may require emergency placement of an endotracheal tube. 
The purpose of the endotracheal tube is to save and sustain the patient’s life. Prior to placement 
of an endotracheal tube, it is common for the supervising medical team to administer a drug 
intravenously to sedate the patient to make this placement of the tube tolerable. Several drugs are 
commonly used for this purpose, including etomidate, ketamine and propofol. Both etomidate 
and ketamine are useful in critically ill patients because they offer relative hemodynamic 
stability compared to propofol.  Ketamine has few, if any, serious long-term side effects. 


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Etomidate is known to suppress adrenal steroidogenesis, and thereby may place patients at risk 
for adrenal insufficiency or death (Coursin et al., 2013). A recent Cochrane Collaboration 
Review concluded that etomidate is associated with increased risk of adrenal dysfunction and 
multi-organ dysfunction in critically ill patients (Bruder et al., 2015). There is ongoing 
controversy regarding the routine use of etomidate in critically ill patients.  
The purpose of the EvK Trial is to compare and contrast the safety of etomidate with 
ketamine in the setting of emergency endotracheal intubation in critically ill patients. In this 
study we will randomize patients to receive either etomidate or ketamine. Our hypothesis is that 
ketamine is associated with increased chance of survival in critically ill patients. The 
proposed mechanism of this effect is that ketamine does not affect the adrenal axis. The specific 
aim of the study is to conduct an adequately powered trial suitable to compare etomidate and 
ketamine in terms of proportions survived at 7-days post-intubation.  The primary endpoint is 
survival at 7 days after intubation. Secondary endpoints include long-term survival (28-day), 
Sequential Organ Failure Assessment (SOFA) scores, anesthetic complications, intubating 
conditions, duration of ventilator support, duration of catecholamine therapy, neurological 
scores, measures of ICU outcomes, measures of long-term functional status, changes in blood 
pressure, new diagnoses, and others. Appendix 1 lists primary and secondary endpoints for the 
study. 
3. Detailed Background, Evaluation of Prior Research and Internal QA/QI Data: 
Both etomidate and ketamine are standard-of-care for emergency endotracheal intubation, 
and both are frequently used locally, nationally and internationally. Etomidate is often used at 
our institution (Parkland Memorial Hospital), based on our last QA/QI survey of our practices 
(Figures 1 and 2). There is considerable controversy regarding the long-term safety of the use of 


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etomidate for emergency endotracheal intubation. The largest study to date that evaluated this 
question (the KETASED Trial, Jabre et al., 2009) randomized patients requiring emergency 
endotracheal intubation to either etomidate (n=234) or ketamine (n=235). The patients who 
received etomidate experienced a much-higher frequency of adrenal dysfunction, and a slight but 
not statistically significant increase in multi-organ dysfunction and mortality. Other published 
reports echo concerns about etomidate. A sub-group analysis within the CORTICUS Trial 
(Sprung et al., 2008) (n=99 receiving etomidate, n=403 receiving other agents) found that one 
dose of etomidate was associated with evidence of adrenal insufficiency and increased mortality 
(Cuthbertson et al., 2009). Another sub-group analysis from a different clinical trial (Arabi et al., 
2010) of cirrhotic patients with septic shock (n=23 receiving etomidate, n=39 receiving other 
agents) reported increased ICU mortality associated with a single dose of etomidate (Cherfan et 
al., 2011). A recent meta-analysis incorporating these and other studies concluded that a single 
dose of etomidate is associated with adrenal insufficiency and increased mortality (Chan et al., 
2012).  
In late 2014 and early 2015 the Department of Anesthesiology at Parkland Memorial 
Hospital performed a Quality Assessment/Quality Improvement (QA/QI) project that evaluated 
techniques and outcomes from emergency endotracheal intubations done by the Anesthesia Code 
Team (ACT). The ACT is responsible for providing emergency endotracheal intubations in many 
locations of the hospital, including the intensive care units, hospital wards, and elsewhere. Over 
the last year, the ACT has performed on average 34 intubations per month (Figure 1). Etomidate 
is frequently utilized for emergency endotracheal intubation by the ACT, Figure 2. Patient 
outcomes are shown in Figure 3. Of note, survival seems worse in patients who have received 
etomidate (Figure 3), even when severity of illness is considered using Sequential Organ Failure 


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Assessment (SOFA) scores (Figure 4). In Figure 4, the calculated SOFA scores in that patients 
receiving etomidate were relatively similar to those receiving propofol (Figure 4), and yet the 
survival seems much worse (Figure 3). Patients receiving no sedative medication had the highest 
SOFA scores (as expected), suggesting a low predicted survival rate. High SOFA scores 
correspond to high predicted mortality. 
The purpose of the EvK Trial is to be the largest trial to date that randomizes critically ill 
patients to etomidate (n=375 patients) versus ketamine (n=375). Additionally, the EvK Trial has 
been designed to address some of the shortcomings of the KETASED trial. First, the KETASED 
trial was not powered to detect a difference in mortality, although did find a trend in survival 
benefit in those patients randomized to receive ketamine. We have designed the EvK Trial to be 
powered to detect a 10% difference in survival in our patient population (See Section 14 for a 
discussion of our statistical approach). Second, the primary endpoint of the KETASED trial was 
the maximum SOFA score in the first 72 hours as the primary endpoint. From our QA/QI data, 
we believe that a more appropriate endpoint in our patient population is survival at Day 7. Third, 
the KETASED trial enrolled a large percentage of patients (approximately 70% in each group) 
who were intubated for “neurological” reasons, and relatively few patients (approximately 10% 
in each group) who were intubated for shock or sepsis. Prior work has suggested that patients 
with sepsis and shock are much more vulnerable to the side effects of etomidate. In our QA/QI 
data, approximately 50% of the patients intubated by the ACT are in shock, and at least 25% 
have sepsis. This suggests that our patient population is more likely to benefit from use of 
ketamine compared to the patient population in KETASED.  
4. Concise Summary of Project: 


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The EvK Trial is a prospective randomized clinical trial that will be done at Parkland 
Memorial Hospital. Individual patients requiring emergency endotracheal intubation will be 
randomized to receive either etomidate (n=375 patients) or ketamine (n=375 patients). The trial 
will be conducted by members of our study team and colleagues in the Departments of 
Anesthesiology, Emergency Medicine, Internal Medicine, Critical Care Medicine, and Surgery, 
in close collaboration with the Department of Pharmacy. The study will be done exclusively at 
Parkland Hospital. A provisional list of collaborators and co-investigators is listed on Page 1 of 
this protocol, and provisional liaison assignments are listed in Appendix 2. The liaisons will help 
orient their colleagues to the study and study procedures. 
 
Figure 5 shows a block diagram of the flow of patients through the study. Eligible 
patients will be identified by the participating medical teams (anesthesia team, emergency 
department, critical care medicine, surgery). Patients will be screened and enrolled by two teams: 
The Anesthesia Code Team (ACT) and/or the Emergency Department  (ED). Pre-randomized 
envelopes will be included in the emergency airway medication boxes used by the Anesthesia 
Code Team and the Emergency Department. Alternatively, these pre-randomized envelopes will 
be immediately available to the aforementioned teams. These envelopes will have inclusion and 
exclusion criteria printed on the outside. Immediately before administering a sedative 
medication, the randomization envelope will be opened, and this will determine which drug a 
patient receives (either etomidate, n=375 patients, or ketamine, n=375 patients). Standard doses 
of these drugs will be recommended to the treating medical teams (etomidate 0.2-0.3 mg per kg 
intravenous, ketamine 1-2 mg per kg intravenous). Other therapies, including vasopressors, 
paralytic agents and other adjunctive agents will be at the discretion of the treating medical and 
surgical teams. Following randomization, study data will be gathered remotely through the EPIC 


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Electronic Medical Record. The only subsequent patient contact will involve post-randomization 
notification of study enrollment, which is discussed below in Appendix 5.  
5. Study Procedures: 
Figure 5 shows a simplified block diagram for how the study will be conducted. 
Individual patients who are in need of emergency endotracheal intubation will be identified by 
the treating medical or surgical teams, many of whom are co-investigators on this project. For 
patients in the Emergency Department (ED), the ED team will screen, randomize and enroll the 
patient. For patients elsewhere in Parkland Hospital, the Anesthesia Code Team (ACT) will 
screen, randomize and enroll the patient. The ACT and ED teams will have access to the study 
randomization envelopes and drug boxes. The drug boxes are already in use by the ACT and ED 
teams. Randomizing a patient in the study will involve opening a pre-printed envelope that will 
be included with the emergency medication boxes, or will be immediately available to the ACT 
or ED teams. The envelopes will have printed inclusion criteria (Section 7) and exclusion criteria 
(Section 8) on the outside to facilitate rapid and accurate screening of patients. The envelopes 
will contain a card that indicates which drug the patient should receive for sedation (etomidate or 
ketamine). Recommended doses of these medications will be printed as well (etomidate 0.2-0.3 
mg / kg intravenous, ketamine 1-2 mg / kg intravenous). All other medical and surgical 
management will be at the discretion of the treating team.  
 
Following randomization the ACT or ED team will notify the Principal Investigator by 
secured internal email or telephone / pager call regarding enrollment of the patient. The study 
team will conduct the remainder of the study retrospectively by extracting information from the 
EPIC Medical Record system to fulfill the primary and secondary endpoints of the study. The 
study will have no impact on the patient’s medical or surgical management, or subsequent care, 


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beyond the initial choice of sedative agent. Formal notification of study enrollment, in accord 
with U.S. Food and Drug Administration regulations, will be performed by the PI and / or Co-
Investigators. A final, written report(s) of the study results will be published in an open, public 
forum. No Protected Health Information (PHI) will be disclosed. The written report(s) will 
include results of the primary and secondary endpoints, in addition to study methodology. We 
will likely also publish an assessment of our Community Notification Plan (Appendix 5). 
6. Sub-Study Procedures: 
None.  
7. Criteria for Inclusion of Subjects: 
A) Adult patient requiring emergency endotracheal intubation at Parkland Memorial 
Hospital. 
8. Criteria for Exclusion of Subjects: 
 
A) Children (<18 years old). 
 
B) Women who are known to be pregnant. 
 
C) Any patient who has been previously randomized in the EvK Trial. 
 
D) Patients who require endotracheal intubation without sedative medication. For  
example, patients in full cardiac arrest. 
E) Patients with a known allergy to ketamine or etomidate. 
F) Any individual wearing a MedAlert bracelet indicating that he/she has formally opted 
out of the EvK trial. These bracelets are discussed below. 
9. Sources of Research Material: 
 
The EvK Trial will be conducted at Parkland Memorial Hospital. The physical location of 
patient enrollment in this trial will include any location in Parkland Memorial Hospital where 


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patients require emergency endotracheal intubation, including the hospital floors (medical and 
surgical), specialty and sub-specialty areas, operating rooms, procedural areas, emergency 
department, intensive care units, and elsewhere in Parkland Memorial Hospital. The sources of 
research material are the patient lists maintained and used by the supervising medical and 
surgical teams. After enrollment in the EvK Trial, data will be gathered retrospectively through 
the EPIC electronic medical records system. No new clinical data will be generated in the 
patient’s chart, other than documentation related to notification of study enrollment, which is 
mandated by the FDA. Eligible patients will be identified by the treating medical and surgical 
teams who are collaborating in the EvK Trial (see Page 1 and Appendix 2), as well as their 
colleagues who have been briefed on trial procedures, inclusion/exclusion criteria, and other 
aspects of the trial. An initial list of list of Co-Investigators is included on the front page of this 
protocol, and a list of study liaisons is attached in Appendix 2. The final list of Co-Investigators 
is likely to include additional individuals who work at Parkland Memorial Hospital and are 
employed by either Parkland Memorial Hospital or UT-Southwestern Medical Center.  
10. Recruitment Methods and Consenting Process: 
Study subjects will be recruited by the supervising medical and surgical teams, including 
the Anesthesia Code Team. Eligible patients will be screened using the inclusion and exclusion 
criteria. The patients enrolled in the study may include individuals under the direct care of the 
study investigators. For this clinical trial it is not possible to obtain written informed consent 
prior to patient enrollment. The U.S. Food and Drug Administration (FDA) published regulations 
regarding this type of research. These regulations are available in FDA 21 CFR 50.24. We will 
formally request to waive pre-enrollment consent. Based on FDA 21 CFR 50.24, we have crafted 
a comprehensive Community Consultation Plan and Post-Enrollment Notification Plan, which is 


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attached in Appendix 5. For participants who are screened but found not eligible for the study: 
No data will be collected on these individuals. For participants who are screened and then 
enrolled in the study: The essential documents will be filed with each individual’s research file, 
which will be maintained in secure storage. 
11. Potential Risks: 
 
The principal medical risks of this study relate to the side effect profiles of ketamine and 
etomidate. Both etomidate and ketamine are standard-of-care medications for emergency 
endotracheal intubation (Jabre et al., 2009). Each drug does have the potential for side effects, 
which include the effects listed below.  
Common adverse reactions to etomidate 
A) Transient venous pain on injection 
B) Transient skeletal movements 
C) Hypoventilation 
D) Hypertension (uncommon) or hypotension (uncommon). Significant changes in blood 
pressure are relatively uncommon with etomidate. 
E) Nausea and/or vomiting 
F) Suppression of adrenal function 
Common Adverse reactions to Ketamine 
A) Hallucinations, delirium 
B) Hypertension (more common, tends to be relatively minor changes) or hypotension (rare) 
C) Hypoventilation 
D) Tachycardia (usually minor) 
E) Nystagmus (involuntary eye movements) 


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As with any clinical research trial, there is a risk of loss of privacy with this study. We 
have a comprehensive strategy to mitigate that risk. That strategy is discussed below in Section 
13.  
12. Subject Safety and Data Monitoring: 
 
Study oversight will include a Data Safety and Monitoring Board (DSMB). The DSMB 
will include specialists from several different specialties including anesthesiology, critical care 
medicine, surgery and pharmacy (Appendix 2). The DSMB will meet quarterly or monthly as 
needed to review all patient enrollments. If necessary the DSMB will meet more often than that 
to review specific study subjects. All study subjects will be reviewed by the DSMB for any 
study-related adverse outcomes. A written record of DSMB meetings will be generated. The IRB 
will be notified in writing of any adverse study-related outcomes, using the existing IRB 
reporting forms.   
13. Procedures to Maintain Confidentiality: 
Study data will be collected and stored at Parkland Memorial Hospital. Dr. Pamela Fox’s 
office in the Department of Anesthesiology will serve as the central node of the study. Her office 
is locked, and a locked storage cabinet will be used to store study-related materials. Her office is 
New Parkland Hospital, Rm# H3119. 
While the study is ongoing, electronic study data will be stored on a password-protected 
laptop computer, and on a password-protected flash drive(s). Study data itself will be maintained 
on a Microsoft spreadsheet file(s) that are maintained on secured computer devices, and on 
handwritten worksheets. The spreadsheet itself will include the study subject’s medical record 
number and birthdate, along with other data relevant to the primary and secondary study 
endpoints. The study worksheets will include a patient demographic sticker. Appendix 3 contains 


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a sample data collection spreadsheet. Appendix 4 contains a sample study worksheet. These 
worksheets will be used to ensure proper follow-up with each study subject. Each subject will be 
given a study number, for example Subject001. Prior to public disclosure of data (for example 
publication of study results), all protected health information including medical record number 
and birthdate will be removed. For the sake of posterity, a confidential file will be maintained 
that links subject number to medical record number. This information will not be disclosed 
publicly. Study data will also be stored on a secured RedCap Database, a sample of which 
appears in Appendix 3. 
 
Paper records that are generated during the study will include individual study subject 
worksheets (Appendix 4) which we will retain in secure storage, and also formal notification 
letters that will be placed in the medical record and/or mailed to enrolled patients and/or their 
families or next of kin (Appendix 13 and 14). Other paper documentation will include records of 
DSMB meetings. Paper records will be stored temporarily in Pam Fox’s office in the locked 
storage cabinet.  
Long-term storage of study data and forms will be in the Department of Anesthesiology 
storage locker. This locker is located in the Bass Building, Lower Level, Storage Unit #53. The 
locker is climate controlled. The physical address is 6303 Forest Park Road, Dallas, TX. The key 
to the storage locker is maintained in the lock box in the Chairperson’s Office Suite. This locker 
is used for long-term storage of clinic records, confidential files and other sensitive documents. 
We have used this storage locker for long-term storage of other research documents (with IRB 
approval). Once the mandatory storage time has elapsed (historically 6 years), study records will 
be destroyed. 


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The research team will have access to the study records and data. No one outside the 
research team will have access to protected health information, with the exception UT-
Southwestern IRB, Parkland Hospital OCR, and any applicable state and federal oversight 
agencies. We anticipate publishing the results of our study in a medical or scientific journal, 
and/or on the internet. Anonymous study data, for example survival curves, study outcomes, and 
anonymous demographic data will be published as part of the report of study results. No PHI will 
be disclosed. We will also publish our methodology, including the methodology used for 
emergency research (Appendix 5). There will likely be several publications that arise from this 
research project.  
14. Potential Benefits: 
 
The purpose of this study is to define which agent, etomidate or ketamine, is associated 
with a greater chance of survival after emergency endotracheal intubation. We believe that the 
increase in the usage of ketamine that will happen as a result of this study is likely to benefit the 
patients at Parkland Hospital directly. In our recent QA/ QI project of emergency endotracheal 
intubations done by the Anesthesia Code Team (ACT) we found that etomidate is commonly 
used for sedation during this procedure. Propofol is also relatively commonly used by the ACT. 
However, in our review of cases we found that etomidate seems to be associated with lower 
long-term survival compared to other agents (Figure 3). In our QA/QI project we also observed 
that propofol is associated with the phenomenon of immediate post-administration cardiac arrest, 
more than any other sedative agent. Thus, we believe that increase in usage of ketamine that will 
happen as a result of this study is likely to benefit the patients at Parkland Hospital directly. 
There are many other potential benefits to patients outside the study, and to society in general. 
Presently etomidate is frequently used for emergency intubation, locally, nationally and 


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internationally. The EvK Trial may clarify if this practice is best for patients, or if the use of 
etomidate should be restricted.  
15. Biostatistics: 
The study is designed and powered to have 80% power with 0.05 level of significance to 
detect a 10% difference in proportions survived at 7-days post endotracheal intubation.  Based on the 
data from our QA/QI project, the proportions of patients survived are assumed to be 85% and 95% 
for the etomidate and ketamine groups, respectively. With these assumptions, n = 750 patients 
(etomidate n=375, ketamine n=375) will be needed to have 80% power. Assuming a 10% screen 
failures (individuals who were randomized, but then never intubated for clinical reasons), we 
anticipate n = 825 will be needed. 
Study subjects will be analyzed in an “intent to treat” manner regardless of what agent(s) 
they receive, as long as they receive an induction agent and are intubated. The primary hypothesis of 
no – difference in proportions survived at 7 days post-intubation will be tested using a chi-square test 
for proportions. Results for the primary study aim will be summarized as p-value and 95% 
confidence interval for difference in proportions survived. Chi-square tests, Fisher’s exact test, 
Student’s t-test and log-rank test will be used to test hypotheses related to secondary end-points. All 
analyses will be done with a 0.05 level of significance. 
Using data from a recent QA/QI project, we estimate that the Anesthesia Code Team 
performs approximately 34 emergency endotracheal intubations per month, or approximately 400 per 
year. Dr. Pease, our collaborator in the Emergency Department, has estimated that the emergency 
department performs approximately 10-20 emergency endotracheal intubations per month, or 
approximately 120 per year. In the operating rooms and related procedural areas, we estimate that the 
department of anesthesia performs approximately 10-20 emergency endotracheal intubations per 
month, or approximately 120 per year. These number combined could provide approximately 640 


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candidate patients that could be enrolled per year. We estimate that it will take up to three years to 
reach a goal of 750 patients enrolled in the study. At the mid-way point of the study, an interim 
analysis will be performed to assess futility using O’Brien-Fleming approach. 
16. Literature References: 
 
Arabi YM, Aljumah A, Daggagh O, Tamim HM, Rishu AH, Al-Abdulkareem A, Knawy BA, 
Hajeer AH, Tamim W, Cherfan A. Low-dose hydrocortisone in patients with cirrhosis and septic 
shock: a randomized controlled trial. CMAJ 2010; 182(18):1971-77. 
 
Bond RM, Fariss CJ, Jones JJ, Kramer ADI, Marlow C, Settle JE, Fowler JH. A 61-million-
person experiment in social influence and political mobilization. Nature 2012; 489:295-98 
 
Broockman DE and Green DP. Do online advertisements increase political candidates’ name 
recognition or favorability? Evidence from randomized field experiments. Political Behavior 
2014; 36:263-89. 
 
Bruder EA, Ball IM, Ridi S, Pickett W, Hohl C. Single induction dose of etomidate versus other 
induction agents for endotracheal intubation in critically ill patients. Cochrane Database 
Systemic Reviews. 2015 Jan 8;1:CD010225. 
 
Chan CM, Mitchell AL, Shorr AF. Etomidate is associated with mortality and adrenal 
insufficiency in sepsis: A meta-analysis. Critical Care Medicine 2012; 40:2945-2953. 
 
Chang and Krosnick. National srveys via RDD telephone interviewing versus the internet. Public 
Opinion Quarterly 2009. 
(http://comm.stanford.edu/faculty/krosnick/docs/2009/2009_poq_chang_rdd.pdf) 
 
Cherfan AJ, Tamim HM, Algumah A, Rishu A, Al-Abdulkareem A, Al-Knawy BA, Hajeer A, 
Tamimi W, Brits R, Arabi YM. Etomidate and mortality in cirrhotic patients with septic shock.  
BMC Clinical Pharmacology 2011; 11:22. 
 
Coursin DB, Fish JT, Joffe AM. Etomidate-Trusted alternative or time to trust alternatives? 
Critical Care Medicine 2013; 41(3):917-9. 
 
Cuthbertson BH, Sprung CL, Annane D, Chevret S, Garfield M, Goodman S, Laterre PF, 
Vincent JL, Freivogel K, Reinhart K, Singer M, Payen D, Weiss YG. The effects of etomidate on 
adrenal responsiveness and mortality in patients with septic shock. Intensive Care Med 2009; 
35:1868-1876. 
 
De la Grandville B, Arroyo D, Walder B. Etomidate for critically ill patients. Con: do you really 
want to weaken the frail? Eur J Anaesthesiol 2012; 29(11):511-4.  
 
Holsti M, Zemek R, Baren J, Stanley RM, Majahan P, Vance C, Brown KM, Gonzalez V, King 
D, Jacobsen K, Shreve K, van de Bruinhorst K, Jones AM, Chamberlain JM. Variation of 


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community consultation and disclosure for a pediatric multi-centered “Exception from Informed 
Consent” trial. Clinical Trials 2015; 12(1):67-76. 
 
Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, 
Beltramini A, Gamand P, Albizzati S et al. Etomidate vs ketamine for rapid sequence intubation 
in acutely ill patients: a multicentre randomized controlled trial. The KETASED Trial. Lancet 
2009; 374: 293-300. 
 
Ledingham IM, Watt I.  Influence of sedation on mortality in critically ill multiple trauma 
patients. Lancet 1983; 1:1270. 
 
McPhee LC, Badawi O, Fraser GL, Lerwick PA, Riker RR, Zuckerman IH, Franey C, Seder DB. 
Single-dose etomidate is not associated with increased mortality in ICU patients with sepsis: 
analysis of a large electronic ICU database. Critical Care Medicine 2013; 41:774-783. 
 
Mongardon N, Singer M. Etomidate versus ketamine for sedation in acutely ill patients. Lancet 
2009; 10;374(9697):1240. 
 
Payen JF. Etomidate for critically ill patients: let us clarify the debate. European Journal of 
Anaesthesiology 2012; 29(11):504-505. 
 
Payen JF, Dupuis C, Trouve-Buisson T, Vinclair M, Bouzat P, Genty C, Monneret D, Faure P, 
Chabre O, Bosson JL. Corticosteroid after etomidate in critically ill patients: a randomized 
controlled trial. Critical Care Med 2012; 40(1):29-35. 
 
Ray DC and McKeown DW. Effect of induction agent on vasopressor and steroid use, and 
outcome in patients with septic shock. Critical Care 2007; 11(3):1-8. 
 
Ray DC and McKeown DW. Etomidate for critically ill patients. Pro: yes we can use it. Eur J 
Anaesthesiol 2012; 29(11):506-10. 
 
Ryan TJ. What makes us click? Demonstrating incentives for angry discourse with digital-age 
field experiments. Journal of Politics 2012; 74(4):1138-52 
 
Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, 
Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payden D, Briegel J, CORTICUS 
Study Group. Hydrocortisone therapy for patients with septic shock. N Engl J Med 2008; 
358:111-124. 
 
Salzman JG, Frascone RJ, Godding BK, Provo TA, Gertner E. Implementing emergency 
research requiring expection from informed consent, community consultation and public 
disclosure. Ann Emerg Med. 2007;50:448-455 
 
Sterling SA, Puskarich MA, Jones AE. The effect of etomidate on mortality in sepsis remains 
unclear. Critical Care Medicine. 2013; 41(6):e95 
 


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Tekwani KL, Watts HF, Sweis RT, Rzechula KH, Kulstad EB. A comparison of the effects of 
etomidate and midazolam on hospital length of stay in patients with suspected sepsis: a 
prospective, randomized study. Annals of Emergency Medicine 2010; (56)5:481-9  
 
Tekwani KL, Watts HF, Rzechula KH, Sweis RT, Kulstad EB. A prospective observational 
study of the effect of etomidate on septic patient mortality and length of stay. Academic 
Emergency Medicine 2009; 16:11-14.  
 
Watt I, Ledingham IM. Mortality amongst multiple trauma patients admitted to an intensive 
therapy unit. Anaesthesia 1984; 39:973-81 
 
Zickuhr K, Smith A. Pew Research Center Digital Differences Paper, 2012. 
http://www.pewinternet.org/2012/04/13/digital-differences/ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Figure 1: Quality Assessment / Quality Improvement (QA/QI) data from emergency 
endotracheal intubations performed by the Anesthesia Code Team (ACT) at Parkland Memorial 
Hospital over the last calendar year (July 2014 – May 2015). June 2015 is omitted. The ACT 
performs, on average, 34 emergency endotracheal intubations each month.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Figure 2: Quality Assessment / Quality Improvement (QA/QI) data from emergency 
endotracheal intubations performed by the Anesthesia Code Team (ACT) at Parkland Memorial 
Hospital over the last calendar year (July 2014 – May 2015). June 2015 is omitted. The ACT 
frequently uses etomidate for emergency endotracheal intubations. This is consistent with local 
and national standards of care. Prior reports have suggested etomidate is used approximately 
60% of the time for emergency endotracheal intubation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Figure 3: Quality Assessment / Quality Improvement (QA/QI) data from emergency 
endotracheal intubations performed by the Anesthesia Code Team (ACT) at Parkland Memorial 
Hospital over the last calendar year (July 2014 – May 2015). June 2015 is omitted. Etomidate is 
associated with lower rates of survival in both historical time periods analyzed.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Figure 4: Quality Assessment / Quality Improvement (QA/QI) data from emergency 
endotracheal intubations performed by the Anesthesia Code Team (ACT) at Parkland Memorial 
Hospital from July – December 2014. Sequential Organ Failure Assessment (SOFA) scores, 
segregated by type of sedative medication used for emergency endotracheal intubation. Higher 
SOFA scores are associated with lower predicted survival. The mean initial SOFA scores in 
patients receiving etomidate are only slightly higher than those receiving propofol, suggesting 
that the starting health status in this analysis is similar. Patients receiving no drug for sedation 
(for example, patients in cardiac arrest), have substantially higher SOFA scores. (S.D. = Standard 
Deviation). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Figure 5: Proposed Study Workflow 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 1: Primary and Secondary Endpoints 
 
Primary Endpoint 
Survival at Day 7 following emergency endotracheal intubation 
 
Secondary Endpoints 
Survival at 28 days following emergency endotracheal intubation 
Sequential Organ Failure Assessment (SOFA) scores 
Immediate outcomes of endotracheal intubation 
Duration of mechanical ventilation  
Duration of catecholamine therapy 
Length of stay in ICU / hospital 
New diagnoses (for example, a diagnosis of adrenal insufficiency) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 2: Provisional Study Liaison Assignments 
 
Data / Informatics Security and Storage Liaison 
Pamela Fox, MD 
 
Dept. of Anesthesiology – MD Liaisons 
Irina Gasanova, MD 
Babatunde Ogunnaike, MD 
John Pennant, MD 
Kendall Tongier, MD 
Gerald Matchett, MD 
Tiffany Moon, MD 
Shaina Drummond, MD 
Girish Joshi, MD 
 
Dept. of Anesthesiology – CRNA Liaisons 
Brian Farrell, CRNA 
Mary (Christi) Sunna, CRNA 
 
Dept. of Emergency Medicine Liaisons 
Paul Pepe, MD 
Ahamed Idris, MD 
 
Dept. of Internal Medicine / Critical Care Medicine Liaison 
Matthew Leveno, MD 
 
Dept. of Surgery Liaisons 
Christian Minshall MD, PhD 
Alexander Eastman, MD 
Tjasa Hranjec, MD 
Michael Cripps, MD 
Brian Williams, MD 
 
Parkland Hospital Pharmacy Liaisons 
Lee Yong, Pharm.D (E.D. Pharmacy Services) 
Jennifer McGuire, Pharm. D 
 
Statistical Design and Oversight 
Abu Minhajudin, Ph.D 
 
Data Safety and Monitoring Board (DSMB) 
Brian Farrell, CRNA, Co-Chair 
Mary (Christi) Sunna, Co-Chair 
Pamela Fox, MD (Anesthesiology Quality Officer, Parkland Division), Co-Chair 
Jennifer McGuire, Pharm.D (O.R. Pharmacy Services) 
Lee Yong, Pharm.D (E.D. Pharmacy Services) 


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Christian Minshall, MD, Ph.D 
Matthew Leveno, MD 
John Pease, MD 
Amanda A. Fox, MD 
Babatunde Ogunnaike, MD 
Gerald Matchett, MD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 3: Draft Data Collection Form (Excel Top, RedCap Bottom) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 4: Draft Study Worksheet.  
 
  
Patient Name / MRN or Sticker   
 
1.  Study Number ___Subject#___________________ 
 
2. Date / Time Enrolled: ______________________________________________________ 
 
3. Enrolling Team (names): ____________________________________________________ 
 
4. Agent Randomized To (circle):   Etomidate    Ketamine.  
Dose_________________mg 
 
 
5. Date 1st Attempt of Notification: ____________.  Method:  Bedside  Phone. Initials:_______ 
Notes: 
 
 
 
6. Date 2nd Attempt of Notification:____________. Method: Bedside  Phone. Initials:________ 
Notes: 
 
 
 
7. Date 3rd Attempt of Notification: _____________. Method: Bedside   Phone. Initials:_______ 
Notes: 
 
 
 
8. If the patient is deceased, send Next-of-Kin Letter. Date:_________. Initials:_____________ 
 
 
9. If the patient is alive, send Last-known-Address Letter. Date:_________. Initials:_________ 
 
 
10. Date of Data Safety and Monitoring Board Review:_________________________________ 
 
11. Study-Related Adverse Outcome?  Yes    No 
 
Notes: 
 
 
 
12.  I affirm that Study Enrollment Notification and DSMB Review are now COMPLETE. 
 
 
 
Name, Signature and Date _____________________________________ 


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Appendix 5: Community Consultation Plan and Post-Enrollment Notification Plan 
 
Community Consultation Plan for the EvK Trial* 
 
*Etomidate versus ketamine for emergency endotracheal intubation: a prospective randomized 
clinical trial 
 
Principal Investigator 
 
Gerald Matchett, MD 
UT-Southwestern Dept. of Anesthesiology 
5323 Harry Hines Blvd, MC 9068 
Dallas, TX 75390-9068 
 
Co-Investigators 
Michael Cripps, MD 
Shaina Drummond, MD 
Alexander Eastman, MD 
Brian Farrell, CRNA 
Pamela Fox, CRNA 
Irina Gasanova, MD 
Tjasa Hranjec, MD 
Ahamed Idris, MD 
Girish Joshi, MD 
Simon Lee, Ph.D 
Matthew Leveno, MD 
Abu Taher Minhajuddin, Ph.D 
Christian Minshall, MD 
Tiffany Moon, MD 
Dawood Nasir, MD 
Babatunde Ogunnaike, MD 
John Pease, MD 
John Pennant, MD 
Mary (Christi) Sunna, CRNA 
William Tongier, MD 
 
Technical Consulting 
Timothy J. Ryan, Ph.D 
 
 
 
 
 
 
 


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Executive Summary 
The EvK Trial will be conducted at Parkland Memorial Hospital by investigators in the 
Departments of Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, 
Surgery, Pharmacy and Clinical Science. The study will randomize critically ill patients who 
require emergency endotracheal intubation to one of two groups: Etomidate or Ketamine. 
Because of the nature of this study – an emergency procedure on a critically ill patient – the 
study will require formal permission to bypass pre-enrollment written informed consent. The 
purpose of this Community Consultation Plan is to fulfill the community consultation 
requirements of the U.S. Food and Drug Administration Title 21 Code of Federal Regulations 
Section 50.24 (hereafter “FDA 21 CFR 50.24”), which governs research in emergency medical 
conditions. The Community Consultation Plan outlined in this document fulfills FDA 21 CFR 
50.24 by outlining a plan to notify community leaders and the public at-large about this research 
study, provisions for study opt-out, and provisions for notification of study enrollment. This plan 
is based on FDA 21 CFR 50.24, and published expert recommendation (Holsti et al., 2015; 
Salzman et al., 2007). 
Background and Rationale for a Community Consultation Plan 
The EvK Trial is a study of the medications given to patients who require emergency 
endotracheal intubation. Study subjects will be randomized to receive one of two drugs 
immediately prior to emergency endotracheal intubation: etomidate or ketamine. Both etomidate 
and ketamine are currently standard-of-care for this procedure. Each drug has unique side 
effects. The EvK Trial will test the hypothesis that ketamine is associated with higher rates of 
survival after emergency endotracheal intubation. The proposed mechanism of this effect is that 
ketamine does not affect the adrenal glands, and therefore is safer for patients requiring 


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emergency endotracheal intubation. Etomidate is known to inhibit normal function of the adrenal 
glands, and may thereby be associated with lower survival rates.  
Traditional medical research that involves human subjects is conducted with written 
informed consent prior to study enrollment. The rationale for obtaining written informed consent 
is to ensure that a patient who enrolls in the study fully understands the risks and benefits of 
participation in the study, and has been given an opportunity to have his/her questions answered. 
Written informed consent is a standard part of non-emergency research that involves human 
subjects. The requirement for pre-enrollment written informed consent is problematic for 
research studies that involve emergency medical care (Holsti et al., 2015; Salzman et al., 2007). 
In emergency situations it may be impractical or impossible to obtain proper written informed 
consent prior to treatment intervention(s). The U.S. Food and Drug Administration (FDA) has 
published guidelines for research that involves emergency medical care (FDA 21 CFR 
50.24).The FDA has determined that pre-enrollment written informed consent may be waived for 
studies of emergency medical care, provided the stipulations outlined in FDA 21 CFR 50.24 are 
met. The EvK Trial qualifies to be conducted without pre-enrollment consent outlined in FDA 21 
CFR 50.24 because it meets the following requirements: 
I. 
The human subjects are in a life-threatening situation that necessitates urgent 
intervention.  
II. 
Available treatments are unproven or unsatisfactory. 
III. 
Collection of valid scientific evidence is necessary to determine the safety and 
effectiveness of the intervention. 
IV. 
Obtaining informed consent is not feasible because the subjects are not able to give 
their informed consent as a result of their medical condition. 


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V. 
The intervention must be administered before consent can be obtained from the 
subject’s legally authorized representative. 
VI. 
There is no reasonable way to identify prospectively individuals likely to become 
eligible for participation.  
VII. 
Participation in the research holds out the prospect of direct benefit to the subjects. 
VIII. 
The clinical investigation could not practically be carried out without the waiver. 
FDA 21 CFR 50.24 mandates that the following stipulations must be met for qualified research 
done under emergency conditions without pre-enrollment written informed consent: 
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. 
II. 
Public disclosure to the communities in which the clinical investigation will be 
conducted and from which the subjects will be drawn, 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. 
IV. 
Establishment of an independent data monitoring committee to exercise oversight of 
the clinical investigation. 
V. 
If obtaining informed consent is not feasible and a legally authorized representative is 
not reasonably available, the investigator 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 


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participation in the clinical investigation. The investigator will summarize efforts 
made to contact family members and make this information available to the IRB at 
the time of continuing review. 
The purpose of this document is to outline the strategy for meeting requirements I-V. 
Prior to implementing any Community Consultation Plan we will obtain approval from the 
institutional review board. Appendix 6 lists a proposed timeline of outreach events for the EvK 
Trial. Appendix 7 shows a graphical representation of our proposed outreach plan. Appendix 8 
lists more than 300 individuals and organizations that we will contact. This list was formulated 
based on local and regional governmental structure, and guided by 2010 census data detailing 
demographic information for the Dallas-Fort Worth area and published expert recommendations 
(Holsti et al., 2015; Salzman et al., 2007). Community outreach will be conducted bilingually 
(English and Spanish), reflecting the two most commonly used languages in Dallas-Fort Worth 
and in Parkland Hospital. Appendix 9 shows a draft letter Outreach to Community Leaders. 
Appendix 10 shows a draft EvK Clinical Trial Website. Appendix 11 shows a draft newpaper 
advertisement. Appendix 12 shows a draft flyer / poster advertisement. Appendices13 and 14 
provide draft documentation related to post-enrollment notification to patients who have been 
enrolled in the study.  
Section I.  Consultation with community representatives and receipt of feedback 
Initial community consultation will involve outreach to individuals who represent the 
larger population from which potential research candidates may be drawn. Community 
consultation will involve direct outreach to municipal, county and federal governmental officials, 
spiritual and other community leaders, media representatives, medical community 
representatives, and Parkland Hospital leadership. Direct outreach to these individuals (or their 


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representatives) will be made in writing. Appendix 8 contains a list of community leaders who 
will be invited to the initial outreach meeting. We plan to invite more than 300 individuals and 
organizations to the community meetings. This number compares favorably to prior reports of 
community notification plans, for example Salzman et al., 2007. In Salzman et al., 2007, a total 
of 127 individuals and organizations were invited to meetings, for a population zone of 
approximately 3.8 million (Minneapolis-St. Paul, the “Twin Cities”). We plan to invite more 
than 300 individuals and organizations for a population zone of approximately 6.5 million 
(Dallas-Fort Worth). In in addition to a formal meetings, the EvK Trial research team will also 
be available to meet with community leaders and community members on an as-needed basis. 
Appendix 9 shows a draft letter that will be sent to community leaders.  
An initial outreach meeting will be scheduled with the aforementioned individuals or 
their representatives in Appendix 8. The background and rationale for the clinical trial will be 
discussed. The clinical trial feedback mechanisms will be presented. A written report of this 
meeting will be generated and sent to the UT-Southwestern IRB and the Parkland Memorial 
Hospital CRO. 
EvK Trial Feedback Mechanisms 
 
There will be multiple avenues for feedback during the community outreach prior to the 
start of enrollment. The web-based feedback mechanisms will continue for the duration of the 
study.  
1. Telephone hotline and opt-out: 214-TBD-TTBD 
2. Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-
Southwestern Medical Center MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-
9068 


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3. Email: tbd@evkclinicaltrial.org 
4. Web-Site (online feedback form): www.evkclinicaltrial.org (or similar, yet to be 
established). A Spanish language version of this website will be created. 
EvK Trial Opt-Out Provision 
Any member of the community who wishes to “opt-out” of any possibility of 
participation in this clinical trial will be given a MedAlert bracelet. This will be provided free of 
charge. Individuals within the catchment area of Parkland Memorial Hospital wishing to 
formally opt-out may do so through the aforementioned feedback mechanisms. 
General content of community notification (including meetings, advertisements, website) 
The content presented in Section I will include broad information about the rationale, 
design, background and study procedures of the EvK Trial. Information will be available in both 
English and Spanish. Specific items to be presented / discussed include the following: 
1. What is emergency endotracheal intubation, and why patients need emergency 
endotracheal intubation. 
2. Current practices for emergency endotracheal intubation, locally and nationally 
3. Background information for which drugs are commonly used for emergency 
endotracheal intubation, and the risks/benefits of common drugs.  
4. An explanation of the EvK Trial study protocol 
5. An explanation for why we cannot gain written informed consent prior to enrolling / 
randomizing patients in this trial 
6. Contact information (feedback mechanisms above) 
Section II. Public notification and receipt of feedback 


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FDA 21 CFR 50.24 mandates that the public be notified directly of the EvK Trial. This 
notification will be done using a three-pronged approach: Direct outreach by community 
meetings, formal advertising and press release in traditional media, posters and / or flyers, and 
formal advertising in online media. This outreach will be done bilingually (English and Spanish), 
which reflects the two most-common languages spoken at Parkland Memorial Hospital. Direct 
community outreach and notification will be guided by the geographic catchment area of 
Parkland Memorial Hospital. Generally this is Dallas County.  
1. Direct Outreach to the Community 
Two community meetings will be scheduled prior to the start of the EvK Trial. 
There will be bilingual information at each meeting (English and Spanish). These 
meetings will be advertised through local news media, and through the study website 
(www.evkclinicaltrial.org, or similar, yet to be established). A draft version of the 
website is included in Appendix 8. The public at-large will be offered a chance to hear 
about the study and have their questions answered. A formal written report of these 
meetings will be generated and sent to the UT-Southwestern IRB and Parkland Hospital 
CRO. In in addition to a formal sit-down meeting, the EvK Trial research team will be 
available to meet with community leaders and members on an as-needed basis. 
There are several additional avenues of community outreach that may be pursued: 
Additional outreach may be conducted in conjunction with leadership of the Parkland 
Hospital COPCs. The Parkland Hospital COPCs have Advisory Groups that may be 
recruited to help facilitate outreach to the community about the study.  Similarly, the UT-
Southwestern Center for Patient Centered Outcomes Research has a Community 
Advisory Panel that may be contacted to help with dissemination of information about 


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the study. Finally, the UT-Southwestern Community Research Registry (a shared 
resource of the Center for Translational Medicine) maintains a database of community 
volunteers who are non-patients, but have agreed to be contacted about research projects. 
Pending budget and availability this database may be enlisted to help with dissemination 
of information.  
2. Formal advertising in traditional media 
The EvK Trial will be advertised by one print advertisement in the Dallas 
Morning News, and in Al Dia Dallas, one of the local Spanish language publications. The 
advertisement will list the study website and feedback mechanisms listed above, and will 
likely appear in both the print and online version of the newspapers. The advertisement 
will notify the public of the community meetings. A draft advertisement is provided in 
Appendix 11. Additionally, Mike Malaise, the Senior Vice President of Communications 
& External Relations at Parkland Memorial Hospital has offered to allow the EvK Trial 
to participate in some of the local advertising that Parkland Memorial Hospital already 
does through other local newspapers, budget and space permitting. These newspapers 
include the Dallas Weekly, Dallas Examiner, El Heraldo News, Dallas Voice, and 
Southern Dallas Magazine. A formal written report of these efforts will be generated and 
sent to the UT-Southwestern IRB and Parkland Hospital CRO.  
3. Formal advertising in online media 
The EvK Trial and study website will be advertised via google charge-per-click 
advertising. These ads will direct the user to the study website, which will provide a 
feedback mechanism listed above. The online advertising will continue as long as the 
study is actively enrolling patients. These advertisements will be directed to the 


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geographic catchment area of Parkland Hospital. Charge-per-click advertising will be 
conducted in both English and Spanish. Additional online media outreach and / or 
advertising will include establishment of a Facebook® page for the trial, and a Twitter® 
page for the trial. A draft of the study website is provided in Appendix 8. The online 
community outreach portions of this protocol are guided by recent published reports that 
support the utility, generally speaking, of online outreach efforts (Bond et al., 2012; Ryan 
2012; Broockman and Green 2013). Additional outreach efforts will include a 
notification submission to the Parkland Memorial Hospital website 
(www.parklandhospital.com), and a similar submission to the UT-Southwestern Medical 
Center website (www.utsouthwestern.edu), and a submission to the weekly “Campus 
Update” email newsletter. 
EvK Trial Feedback Mechanisms 
There will be multiple avenues for feedback during the community outreach prior to the 
start of enrollment. The web-based feedback mechanisms will continue for the duration of the 
study.  
1. Telephone hotline and opt-out: 214-TBD-TTBD 
2. Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-
Southwestern Medical Center MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-
9068 
3. Email: tbd@evkclinicaltrial.org 
4. Web-Site (online feedback form): www.evkclinicaltrial.org (or similar, yet to be 
established). A Spanish language version of this website will be created. 
EvK Trial Opt-Out Provision 


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Any member of the community who wishes to “opt-out” of any possibility of 
participation in this clinical trial will be given a MedAlert bracelet. This will be provided free of 
charge. Individuals within the catchment area of Parkland Memorial Hospital wishing to 
formally opt-out may do so through the aforementioned feedback mechanisms. 
General content of community notification (including meetings, advertisements, website) 
The content presented to in Section I will include broad information about the rationale, 
design, background and study procedures of the EvK Trial. Information will be available in both 
English and Spanish language versions. Specific items to be presented / discussed include the 
following: 
1. What is emergency endotracheal intubation, and why patients need emergency 
endotracheal intubation. 
2. Current practices for emergency endotracheal intubation, locally and nationally. 
Specifically which drug(s) are commonly used for this procedure. 
3. Background information for which drugs are commonly used for emergency 
endotracheal intubation, and the risks/benefits of common drugs.  
4. An explanation of the EvK Trial study protocol. 
5. An explanation for why we cannot gain written informed consent prior to enrolling / 
randomizing patients in this trial. 
6. Contact information (feedback mechanisms above). 
Assessment of Feasibility of Providing In-Hospital Handouts to Elective Hospital 
Admission patients and ED patients regarding the study 
 
We assessed the feasibility of providing a handout to every single ED patient and hospital 
patient as a means of providing broad notification about the study, with contact number for 


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questions, to provide an indication of the willingness of subjects at-risk for emergency intubation 
to participate in the study. In theory it would be good to identify patients at high-risk for needing 
emergency intubation. However, we believe that it is very difficult to identify a group of patients 
who are stable enough on admission to read and comprehend a form, but who are at subsequent 
risk of being intubated. Clinically speaking we believe that this group of patients is likely to be 
vanishingly small. What’s far, far more common is that a patient comes into the ED in a 
critically ill “unstable” medical state, in no position to reasonably read and comprehend a form, 
and shortly thereafter requires emergency intubation. Based on this workflow we do not believe 
it is feasible to identify and notify patients who are especially at-risk for needing emergency 
endotracheal intubation.  
Assessment of Results of Community Consultation Plan 
Throughout the study we will track the results of our Community Consultation Plan. 
Based on published expert opinion, we estimate that attendance at our community meetings may 
be approximately10 attendees for every 100 invitations (Salzman et al., 2007) based on direct 
invitation by mail alone. We will send direct invitation by mail to more than 300 individuals and 
organizations listed in Appendix 6, which suggests about 30 individual attendees from this effort 
alone. The print advertisements will appear in Al Dia Dallas (circulation 225,000) and the Dallas 
Morning News (circulation 400,000) will likely push this number upward, as will the direct 
outreach to the Parkland Hospital and UT-Southwestern Medical Center communities. Charge-
per-click advertising will also likely push the number of attendees upward.  
Online charge-per-click advertising through www.google.com will begin prior to patient 
enrollment, and continue on a continuous basis until enrollment for the study is complete. 
Google advertising tracks metrics such as “ad impressions,” “click through rate,” and other 


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quantitative metrics which we will be able to report in the continuing reviews of this study. 
Similarly, Facebook and Twitter accounts will offer quantitative metrics that we will report and 
follow. We will also be able to report total number of website visits to our trial website, 
provisionally www.evkclinicaltrial.org. We expect that ad impressions through google will 
number in the hundreds or thousands over the life of the study, and possibly more than that.  
Budget permitting we plan to purse polling of individuals in Dallas County to test the 
impact of our community outreach, using an approach based on research published previously 
(Bond et al., 2012; Ryan 2012; Broockman and Green 2013). In constructing the study we 
evaluated both online and telephone dialing protocol we solicited bids for both online polling and 
telephone polling. We received written bids from four companies: Google Consumer Surveys, 
WinningConnections Polling, PremiereReporting Polling, and AAM Political Polling. Telephone 
polling is outside of our financial means for the study, and so we will focus on online polling.  
Internet-based online polling has been validated compared to Random Digit Dialing 
(RDD) telephone poling in at least one study to date (Chang and Krosnick 2009). Online polling 
is heavily used in National Science Foundation (NSF)-Funded projects, for example the 
American National Election Study (http://www.electionstudies.org/).  Recent work by the Pew 
Research Center from 2012 has reported that “Both African Americans and English-Speaking 
Latinos are as likely as whites to own any sort of mobile phone, and are more likely to use their 
platform for a wider range of activities (Zikuhr and Smith 2012).” In the opinion of our 
consulting political scientist Prof. Timothy J. Ryan, online survey-based polling without RDD is 
a reasonable approach for evaluating our CCP (Personal Communication from Prof. Ryan 
11/9/2015). 


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Section III. Public disclosure of sufficient information following completion of the clinical 
investigation to apprise the community and researchers of the study 
The EvK Trial will be registered with the US federal government at 
www.clinicaltrials.gov. Results from the study will be published on that website in accordance 
with federal law. Additionally, following completion of the EvK Trial, we intend to make our 
findings publically known through one of the following mechanisms: publishing study results in 
a medical journal and/or publishing study results in news releases and news reports. The study 
website (provisionally www.evkclinicaltrial.org) will provide a link to www.clinicaltrials.gov, 
and will provide links to study results and may list study results directly. 
Section IV. Establishment of an independent data monitoring committee to exercise 
oversight of the clinical investigation 
The EvK Trial will be overseen by a Data Safety Monitoring Board (DSMB) that is 
chaired or co-chaired by an individual(s) other than the principal investigator. This committee 
will meet quarterly or monthly, or more often if needed, to evaluate progress of the study and 
review individual cases for any adverse study events. Specific items that the DSMB will review 
include study accrual rate, the global experience of study participants, study attrition rate, 
patterns of study-related Adverse Events, patterns of protocol deviations and/or violations, and 
any changes in the risks or benefits of the study. Appendix 2 contains a provisional list of 
members of the DSMB.  
Section V. Subsequent Notification of Patient Enrollment 
Per FDA 21 CFR 50.24, investigators must attempt to notify all patients that they have 
been enrolled in a research study. In the event the patient is unable to comprehend notification, 


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or is deceased, reasonable attempts at notification of the patient’s surrogates, legal guardians or 
next-of-kin must be made. The EvK Trial will comply with these provisions.  
Following enrollment in the study, the study team will assess for the patient’s ability to 
discuss the clinical trail. Given the nature of this study (emergency endotracheal intubation), it is 
exceedingly unlikely that the patient will be able to participate in any meaningful discussion of 
research immediately after enrollment. In the rare circumstance that the individual patient is able 
to participate in a meaningful discussion in a timely way, then the study team will discuss the 
nature of the research project, its goals and objectives and the study protocols. The study team 
will give a letter notifying the patient of his/her enrollment into their medical record (Appendix 
13). This will be documented in the patient’s study worksheet (Appendix 4), and will complete 
the notification process. 
For a large percentage of patients enrolled in this trial, we anticipate that the patients will 
not be able to have a meaningful discussion about the study immediately after enrollment, and 
possibly not for many days after enrollment. In this case, the study investigators will attempt to 
contact the patient’s surrogates, legal guardians or next of kin, either in person at the patient’s 
bedside or by telephone. If the aforementioned parties can be reached, the EvK Trial team will 
discuss the nature of the research project, its goals and objectives and the study protocols. If the 
family, surrogates, legal guardians or next-of-kin can be reached in person at the bedside or by 
telephone, the notification process will be considered complete.  
 If the family, surrogates, legal guardians or next-of-kin cannot be reached in person or 
by telephone, the EvK Trial team will send a letter to the patient’s last known physical address 
(Appendix 14). The letter in Appendix 13 will be sent in the event that the patient is alive. In the 


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event that the patient is deceased, the research team will send the letter in Appendix 14. All of 
this will be documented in the patient’s study worksheet on the Study Worksheet (Appendix 4).  
During the notification process we will verbally request permission to use the patient’s 
anonymous data. If verbal permission is granted, we will document that. If permission is denied, 
we will remove the patient’s data from the study (from the point of denial of permission 
onward). Following these efforts, the EvK Trial team will do one of the following: 
1. Document successful notification of the patient or family. 
2. Document no response from attempts at bedside and telephone contact. 
Summary of the Community Notification Plan for the EvK Trial 
The EvK Trial is a prospective randomized study that will randomize patients under 
emergency circumstances to receive either etomidate or ketamine for emergency endotracheal 
intubation. Because of the nature of emergency intubation, obtaining written informed consent 
prior to enrollment in the EvK Trial is not possible. In order to comply with current FDA 
guidelines for non-consented emergency research (FDA 21 CFR 50.24), the Community 
Consultation Plan in this document presents a broad-based approach to notify community leaders 
and community members, using traditional media as well as online media and direct community 
meetings. Patients (or their next-of-kin) enrolled in the EvK Trial will be notified of enrollment 
in accordance with FDA guidelines. Individuals in the catchment area of Parkland Memorial 
Hospital who wish to avoid any possibility of participation in the EvK Trial will be given a free 
MedAlert bracelet indicating that wish. 
 
 
 
 
 
 
 


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Appendix 6: Provisional Approximate Timeline of Community Consultation Plan Outreach 
 
Start of Campaign: After IRB and Parkland Memorial Hospital CRO approval, the study 
website www.evkclinicaltrial.org , www.clinicaltrials.gov, Facebook Profile, and Twitter Profile 
will go live but are silent. 
Day 0: Anonymous online polling within the zip-code catchment area (~$600): Sample potential 
question: Have you heard of the EvK Clinical Trial at Parkland Hospital Y/N? 
Day 7: Letters go out, Handouts/Posters placed, Newspaper Ads Published, Websites “turned 
on.” Online advertising starts for Zip codes in initial group (Group A) 
Day 35: Anonymous online polling within the zip-code catchment area (~$600): Sample 
potential question: Have you heard of the EvK Clinical Trial at Parkland Hospital Y/N? Online 
advertising starts for Zip codes in secondary group (Group B). 
Day 63: Anonymous online polling within the zip-code catchment area (~$600): Sample 
potential question:  Have you heard of the EvK Clinical Trial at Parkland Hospital Y/N? 
Advertising online continues in all zip codes at low level going forward. Start of internal email 
campaign within UT/ PHHS systems. Internal website ads placed if approved. 
Day 77: Anonymous online polling within the zip-code catchment area (~$600): Sample 
potential question: Have you heard of the EvK Clinical Trial at Parkland Hospital Y/N?   
Day 78-90: Community & Leader Meetings 
Day 91: Anonymous online polling within the zip-code catchment area (~$3000-4500): This 
may be more comprehensive polling with several questions about knowledge of the study, basic 
demographic information, measurements of how people feel about the study, measurements of 
opinion of potential benefit of the study.  
Day 92 Onward: A website presence will be maintained, as will online outreach and advertising 
for the duration of active patient enrollment. The results of these efforts will be reported with 
CRs. Following the last community meeting, we will gather data from the community outreach, 
including number of advertising impressions, number of website clicks, metrics from Facebook 
and Twitter, direct website contacts, and direct data (budget permitting). A detailed report of the 
results of the will be created and submitted to the IRB. Enrollment begins if/when the IRB and 
Parkland Memorial Hospital CRO gives the formal go-ahead 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 7: Graphical description of approximate timing of outreach events.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 8: Draft List of Community Leaders and Organizations for Community Consultation 
 
Municipal Governmental Officials 
1. Mike Rawlings, Mayor of Dallas, 1500 Marilla Street, Room 5EN, Dallas, TX 75201 
2. Monica R. Alonzo, District 6 Representative and Mayor Pro Tem, 1500 Marilla Street, 
Room 5EN, Dallas, TX 75201 
3. Erik Wilson, District 8 Representative and Deputy Mayor Pro Tem, 1500 Marilla Street, 
Room 5EN, Dallas, TX 75201 
4. Scott Griggs, District 1 Representative, 1500 Marilla Street, Room 5EN, Dallas, TX 75201 
5. Adam Medrano, District 2 Representative, 1500 Marilla Street, Room 5EN, Dallas, TX 
75201 
6. Casey Thomas II, District 3 Representative, 1500 Marilla Street, Room 5EN, Dallas, TX 
75201 
7. Carolyn King Arnold, District 4 Representative, 1500 Marilla Street, Room 5EN, Dallas, 
TX 75201 
8. Rickey D. Callahan, District 5 Representative, 1500 Marilla Street, Room 5EN, Dallas, 
TX 75201 
9. Tiffany A. Young, District 7 Representative, 1500 Marilla Street, Room 5EN, Dallas, TX 
75201 
10. Mark Clayton, District 9 Representative, 1500 Marilla Street, Room 5EN, Dallas, TX 
75201 
11. B. Adam McGough, District 10 Representative, 1500 Marilla Street, Room 5EN, Dallas, 
TX 75201 
12. Lee Kleinman, District 11 Representative, 1500 Marilla Street, Room 5EN, Dallas, TX 
75201 
13. Sandy Greyson, District 12 Representative, 1500 Marilla Street, Room 5EN, Dallas, TX 
75201 
14. Jennifer Staubach Gates, District 13 Representative, 1500 Marilla Street, Room 5EN, 
Dallas, TX 75201 
15. Philip T. Kingston, District 14 Representative, 1500 Marilla Street, Room 5EN, Dallas, 
TX 75201 
16. A.C. Gonzalez, Dallas City Manager, 1500 Marilla Street, Room 5EN, Dallas, TX 75201 
17.  Forest E. Turner, Chief Wellness Officer, 1500 Marilla Street, Room 5DN, Dallas, TX 
75201 
18. Cheryl D. Orr, Dallas Ethics and Diversity Officer, 1500 Marilla Street, Room 5EN, 
Dallas, TX 75201 
19. Matthew Marchant, Mayor of Carrollton, 1945 E. Jackson Road, Carrollton, TX 75006 
20. James Lawrence, Councilmember, 1945 E. Jackson Road, Carrollton, TX 75006 
21. Anthony Wilder, Councilmember and Carrollton Mayor Pro Tem, 1945 E. Jackson Road, 
Carrollton, TX 75006 


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22. Doug Hrbacek, Councilmember and Carrollton Deputy Mayor Pro Tem, 1945 E. Jackson 
Road, Carrollton, TX 75006 
23. Bob Garza, Councilmember, 1945 E. Jackson Road, Carrollton, TX 75006 
24. Glen Blanscet, Councilmember, 1945 E. Jackson Road, Carrollton, TX 75006 
25. Steve Babick, Councilmember, 1945 E. Jackson Road, Carrollton, TX 75006 
26. John Sutter, Councilmember, 1945 E. Jackson Road, Carrollton, TX 75006 
27. Leonard Martin, Carrollton City Manager, 1945 E. Jackson Road, Carrollton, TX 75006 
28. Stan Pickett, Mayor of Mesquite, P.O. BOX 850137, Mesquite, TX 75185-0137 
29. Bill Porter, Councilmember, P.O. BOX 850137, Mesquite, TX 75185-0137 
30. Jeff Casper, Councilmember, P.O. BOX 850137, Mesquite, TX 75185-0137 
31. Bruce Archer, Councilmember and Deputy Mayor Pro Tem, P.O. BOX 850137, 
Mesquite, TX 75185-0137 
32. Shirley Roberts, Councilmember, P.O. BOX 850137, Mesquite, TX 75185-0137 
33. Greg Noschese, Councilmember and Mayor Pro Tem, P.O. BOX 850137, Mesquite, TX 
75185-0137 
34. Dennis Tarpley, Councilmember, P.O. BOX 850137, Mesquite, TX 75185-0137 
35. Ted Barron, Mesquite City Manager, P.O. BOX 850137, Mesquite, TX 75185-0137 
36. Ron Jensen, Mayor of Grand Prairie, 317 W College St. P.O. BOX 534045, Grand 
Prairie, TX 75053 
37. Jorja Clemson, Councilmember, 317 W College St. P.O. BOX 534045, Grand Prairie, TX 
75053 
38. Jim Swafford, Councilmember, 317 W College St. P.O. BOX 534045, Grand Prairie, TX 
75053 
39. Lila Thorn, Councilmember, 317 W College St. P.O. BOX 534045, Grand Prairie, TX 
75053 
40. Richard Fregoe, Councilmember, 317 W College St. P.O. BOX 534045, Grand Prairie, 
TX 75053 
41. Tony Shotwell, Councilmember, 317 W College St. P.O. BOX 534045, Grand Prairie, 
TX 75053 
42. Jeff Wooldridge, Councilmember, 317 W College St. P.O. BOX 534045, Grand Prairie, 
TX 75053 
43. Jeff Copeland, Councilmember, 317 W College St. P.O. BOX 534045, Grand Prairie, TX 
75053 
44. Greg Giessner, Councilmember, 317 W College St. P.O. BOX 534045, Grand Prairie, TX 
75053 
45. Beth Van Duyne, Mayor of Irving, 825 W. Irving Blvd. Irving, TX 75060 
46. Chris Hillman, City Manager of Irving, 825 W. Irving Blvd. Irving, TX 75060 
47. John C. Danish, Councilmember, 825 W. Irving Blvd. Irving, TX 75060 
48. Allan E. Meagher, Councilmember, 825 W. Irving Blvd. Irving, TX 75060 


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49. Dennis Webb, Mayor Pro Tem and Councilmember, 825 W. Irving Blvd. Irving, TX 
75060 
50. Phil Riddle, Councilmember, 825 W. Irving Blvd. Irving, TX 75060 
51. Oscar Ward, Councilmember, 825 W. Irving Blvd. Irving, TX 75060 
52. Brad M. LaMorgese, Deputy Mayor Pro Tem and Councilmember, 825 W. Irving Blvd. 
Irving, TX 75060 
53. Gerald Farris, Councilmember, 825 W. Irving Blvd., Irving, TX 75060 
54. David Palmer, Councilmember, 825 W. Irving Blvd., Irving, TX 75060 
55. Carl Sherman, Mayor of DeSoto, 211 East Pleasant Run Road, DeSoto, TX 75115 
56. Virgil Helm, Councilmember, 211 East Pleasant Run Road, DeSoto, TX 75115 
57. Kristine Clark, Councilmember, 211 East Pleasant Run Road, DeSoto, TX 75115 
58. Rachel Proctor, Councilmember, 211 East Pleasant Run Road, DeSoto, TX 75115 
59. Dick North, Councilmember, 211 East Pleasant Run Road, DeSoto, TX 75115 
60. Curtistene McCowan, Councilmember, 211 East Pleasant Run Road, DeSoto, TX 75115 
61. James Zander, Councilmember, 211 East Pleasant Run Road, DeSoto, TX 75115 
62. Marcus E. Knight, Mayor of Lancaster, 211 N. Henry Street, Lancaster, TX 75146 
63. Carol Strain-Burk, Councilmember, 211 N. Henry Street, Lancaster, TX 75146 
64. James Daniels, Mayor Pro Tem and Councilmember, 211 N. Henry Street, Lancaster, TX 
75146 
65. Stanley Jaglowski, Councilmember, 211 N. Henry Street, Lancaster, TX 75146 
66. LaShonjia Harris, Deputy Mayor Pro Tem and Councilmember, 211 N. Henry Street, 
Lancaster, TX 75146 
67. Marco Mejia, Councilmember, 211 N. Henry Street, Lancaster, TX 75146 
68. Nina Morris, Councilmember, 211 N. Henry Street, Lancaster, TX 75146 
69. Douglas Athas, Mayor of Garland, 200 N. Fifth Street, Garland TX 75040 
70. Tim Campbell, Deputy Mayor Pro Tem and Councilmember, 200 N. Fifth Street, 
Garland TX 75040 
71. Anita Goebel, Councilmember, 200 N. Fifth Street, Garland TX 75040 
72. Stephen W. Stanley, Councilmember, 200 N. Fifth Street, Garland TX 75040 
73. B.J. Williams, Councilmember, 200 N. Fifth Street, Garland TX 75040 
74. Billy Mack Williams, Councilmember, 200 N. Fifth Street, Garland TX 75040 
75. Lori Barnett Dodson, Councilmember, 200 N. Fifth Street, Garland TX 75040 
76. Scott LeMay, Councilmember, 200 N. Fifth Street, Garland TX 75040 
77. Jim Cahill, Mayor Pro Tem and Councilmember, 200 N. Fifth Street, Garland TX 75040 
78. Paul Voelker, Mayor of Richardson, P.O. Box 830309 Richardson, TX 75083-0309 
79. Mark Solomon, Mayor Pro Tem and Councilmember, P.O. Box 830309 Richardson, TX 
75083-0309 
80. Bob Townsend, Councilmember, P.O. Box 830309 Richardson, TX 75083-0309 
81. Scott Dunn, Councilmember, P.O. Box 830309 Richardson, TX 75083-0309 
82. Mabel Simpson, Councilmember, P.O. Box 830309 Richardson, TX 75083-0309 


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83. Marta Gomez Frey, Councilmember, P.O. Box 830309 Richardson, TX 75083-0309 
84. Steve Mitchell, Councilmember, P.O. Box 830309 Richardson, TX 75083-0309 
85. Harry LaRosiliere, Mayor of Plano, 1520 K Avenue, Plano, TX 75074 
86. Angela Miner, Councilmember, 1520 K Avenue, Plano, TX 75074 
87. Ben Harris, Councilmember and Deputy Mayor Pro Tem, 1520 K Avenue, Plano, TX 
75074 
88. Rick Grady, Councilmember, 1520 K Avenue, Plano, TX 75074 
89. Lissa Smith, Councilmember and Mayor Pro Tem, 1520 K Avenue, Plano, TX 75074 
90. Ron Kelley, Councilmember, 1520 K Avenue, Plano, TX 75074 
91. Tom Harrison, Councilmember, 1520 K Avenue, Plano, TX 75074 
92. David Downs, Councilmember, 1520 K Avenue, Plano, TX 75074 
93. David L. Green, Mayor of Duncanville, P.O. Box 380280 Duncanville, TX 75138-0280 
94. Dennis L. Schwartz, Councilmember, P.O. Box 380280 Duncanville, TX 75138-0280 
95. Steven Rutherford, Councilmember, P.O. Box 380280 Duncanville, TX 75138-0280 
96. Leslie Thomas, Councilmember, P.O. Box 380280 Duncanville, TX 75138-0280 
97. Ronald L. Dotson, Councilmember, P.O. Box 380280 Duncanville, TX 75138-0280 
98. Johnette Jameson, Councilmember, P.O. Box 380280 Duncanville, TX 75138-0280 
99. Patrick Harvey, Councilmember, P.O. Box 380280 Duncanville, TX 75138-028 
100. Betsy Price, Mayor of Fort Worth, 1000 Throckmorton St., Fort Worth, TX 76102 
101. Sal Espino, Councilmember, 1000 Throckmorton St., Fort Worth, TX 76102 
102. W.B. Simmerman, Councilmember, 1000 Throckmorton St., Fort Worth, TX 76102 
103. Cary Moon, Councilmember, 1000 Throckmorton St., Fort Worth, TX 76102 
104. Gyna Bivens, Councilmember, 1000 Throckmorton St., Fort Worth, TX 76102 
105. Jungus Jordan, Councilmember, 1000 Throckmorton St., Fort Worth, TX 76102 
106. Dennis Shingleton, Councilmember, 1000 Throckmorton St., Fort Worth, TX 76102 
107. Kelly Allen Gray, Councilmember, 1000 Throckmorton St., Fort Worth, TX 76102 
108. Ann Zadeh, Councilmember, 1000 Throckmorton St., Fort Worth, TX 76102 
109. Jeff Williams, Mayor of Arlington, 101 E. Abram St., Arlington TX 76010 
110. Sheri Capehart, Councilmember, 101 E. Abram St., Arlington TX 76010 
111. Charlie Parker, Councilmember, 101 E. Abram St., Arlington TX 76010 
112. Robert Rivera, Councilmember, 101 E. Abram St., Arlington TX 76010 
113. Kathryn Wilemon, Councilmember, 101 E. Abram St., Arlington TX 76010 
114. Lana Wolff, Councilmember, 101 E. Abram St., Arlington TX 76010 
115. Robert Shepard, Councilmember, 101 E. Abram St., Arlington TX 76010 
116. Jimmy Bennett, Councilmember, 101 E. Abram St., Arlington TX 76010 
117. Michael Glaspie, Councilmember, 101 E. Abram St., Arlington TX 76010 
118. Carrie Marshall, Mayor of Balch Springs, 13503 Alexander Rd, Balch Springs, TX 
75181 
119. Rodney Taylor, Councilmember, 13503 Alexander Rd, Balch Springs, TX 75181 


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120. Theresa M. Burnett, Mayor Pro Tem of Balch Springs, 13503 Alexander Rd, Balch 
Springs, TX 75181 
121. Steven Gorwood, Councilmember, 13503 Alexander Rd, Balch Springs, TX 75181 
122. Charlene Rushing, Councilmember, 13503 Alexander Rd, Balch Springs, TX 75181 
123. Wanda Adams, Councilmember, 13503 Alexander Rd, Balch Springs, TX 75181 
124. Tartisha Hill, Councilmember, 13503 Alexander Rd, Balch Springs, TX 75181 
125. Susan Cluse, City Manager of Balch Springs, 13503 Alexander Rd, Balch Springs, TX 
75181 
County Governmental Officials 
1. Clay Lewis Jenkins, Dallas County Judge, 411 Elm St., Dallas, TX 75202 
2. Dr. Theresa Daniel, District 1 County Commissioner, 411 Elm St., Dallas, TX 75202 
3. Mike Cantrell, District 2 County Commissioner, 411 Elm St., Dallas, TX 75202 
4. John Wiley Price, District 3 County Commissioner, 411 Elm St., Dallas, TX 75202 
5. Dr. Elba Garcia, District 4 County Commissioner, 411 Elm St., Dallas, TX 75202 
6. Zach Thompson, Dallas County Health & Human Services Director, 411 Elm St., Dallas, 
TX 75202 
Federal Governmental Officials 
1. Eddie Bernice Johnson, Texas 30th District, Dallas Area Congressperson, 3102 Maple 
Avenue, Suite 600, Dallas, TX 75201 
2. Pete Sessions, Texas 32nd District, Dallas Area Congressperson, Park Central VII, 12750 
Merit Drive, Suite 1434, Dallas, TX 75215-1229 
Media Representatives 
1. Managing Editor, Fox Channel 4 TV News, 400 N. Griffin Street, Dallas TX 75202 
2. Managing Editor, NBC Channel 5 TV News, 4805 Amon Carter Blvd., Fort Worth, TX 
76155  
3. Managing Editor, Telemundo Channel 39 TV News, 4805 Amon Carter Blvd., Fort 
Worth, TX 76155  
4. Managing Editor, ABC Channel 8 TV News, 606 Young Street, Dallas, TX 75202 
5. Managing Editor, CBS Channel 11 TV News, 12001 N. Central Expressway, Suite 1300, 
Dallas, TX 75243 
6. Managing Editor, Dallas Morning News, 508 Young St., Dallas, TX 75202  
7. Managing Editor, Al Dia Dallas, 508 Young St., Dallas, TX 75202 
8. Managing Editor, KRLD News Radio 1080 AM, 4131 North Central Expressway, Suite 
100, Dallas, TX 75204 
9. Managing Editor, KFLC Univision Radio America 1270 AM, 3102 Oak Lawn Avenue, 
Fort Worth, TX 75219 
Parkland Hospital Leadership  


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1. Debbie Branson, Parkland Hospital Board Chair, 5200 Harry Hines Blvd, Dallas, TX 
75235 
2. Jerry Bryant, Parkland Hospital Board Member, 5200 Harry Hines Blvd, Dallas, TX 
75235 
3. Patricia Rodriguez Gorman, Parkland Hospital Board Vice Chair, 5200 Harry Hines 
Blvd, Dallas, TX 75235 
4. Dr. Winfred Parnell, Parkland Hospital Board Member, 5200 Harry Hines Blvd, Dallas, 
TX 75235 
5. Dr. Scherry Johnson, Parkland Hospital Board Member, 5200 Harry Hines Blvd, Dallas, 
TX 75235 
6. Dr. Paula Dobbs-Wiggins, Parkland Hospital Board Member, 5200 Harry Hines Blvd, 
Dallas, TX 75235 
7. Dr. Stephanie Woods, Parkland Hospital Board Member, 5200 Harry Hines Blvd, Dallas, 
TX 75235 
8. Dr. Frederick Cerise, President and Chief Executive Officer of Parkland Health and 
Hospital System, 5200 Harry Hines Blvd, Dallas, TX 75235 
9. Dr. Jim Dunn, Executive Vice President and Chief Talent Officer, 5200 Harry Hines 
Blvd, Dallas, TX 75235 
10. Mary Findley, Senior Vice President and Chief Compliance and Ethics Officer, 5200 
Harry Hines Blvd, Dallas, TX 75235 
11. Kris Gaw, Executive Vice President and Chief Administrative Officer – Hospital 
Operations, 5200 Harry Hines Blvd, Dallas, TX 75235 
12. Dr. Ron Laxton, Executive Vice President and Chief Operating Officer, 5200 Harry 
Hines Blvd, Dallas, TX 75235 
13. Paul Leslie, Executive Vice President and General Council, 5200 Harry Hines Blvd, 
Dallas, TX 75235 
14. John Moore, Executive Vice President and Chief Financial Officer, 5200 Harry Hines 
Blvd, Dallas, TX 75235 
15. Sharon Phillips, Executive Vice President and Chief Administrative Officer – Population 
Health, 5200 Harry Hines Blvd, Dallas, TX 75235 
16. Michael Malaise, Senior Vice President of Communications and External Affairs, 5200 
Harry Hines Blvd, Dallas, TX 75235 
17. Dr. Esmaeil Porsa, Interim Chief Medical Officer, 5200 Harry Hines Blvd, Dallas, TX 
75235 
18. Karen Watts, Executive Vice President and Chief Nursing Officer, 5200 Harry Hines 
Blvd, Dallas, TX 75235 
19. Dr. Carlos E. Girod, President of the Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 
75235 
20. Dr. Teresa V. Chan, Vice President of the Medical Staff, 5200 Harry Hines Blvd, Dallas, 
TX 75235 


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21. Dr. Waseem Ahmed, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 
75235 
22. Dr. Muthusamy Anandkumar, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, 
TX 75235 
23. Dr. Steven Bloom, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 75235 
24. Dr. Robert S. Hendler, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 
75235 
25. Dr. Joseph P. Minei, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 
75235 
26. Dr. Kyle Molberg, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 75235 
27. Dr. Brett Moran, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 75235 
28. Dr. Babatunde Ogunnaike, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 
75235 
29. Dr. John P. Pease, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 75235 
30. Dr. Donna Persaud, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 75235 
31. Dr. Ronald J. Rejzer, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 
75235 
32. Dr. Noel O. Santini, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 75235 
33. Dr. Susan Spalding, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 75235 
34. Dr. Pranavi Sreeramoju, Member of Medical Staff, 5200 Harry Hines Blvd, Dallas, TX 
75235 
35. Dr. Alex Eastman, Director of Trauma Services at Parkland Hospital, 5200 Harry Hines 
Blvd, Dallas, TX 75235 
36. Susan Partridge, Vice President for Clinical Research at Parkland Hospital, 5200 Harry 
Hines Blvd, Dallas, TX 75235 
37. Dr. Marie Jackson, Director of Research Services at Parkland Hospital, 5200 Harry Hines 
Blvd, Dallas, TX 75235 
38. Suzanne Simms, Vice President of Perioperative Services at Parkland Hospital, 5200 
Harry Hines Blvd, Dallas, TX 75235 
 
Medical Community Representatives 
1. Dr. Jim W. Walton, President of the Dallas County Medical Society, P.O. Box 4680 
Dallas, TX 75208-0680 
2. Dr. Lee Ann Pearse, President-Elect of the Dallas County Medical Society, P.O. Box 
4680 Dallas, TX 75208-0680 
3. Dr. John T. Carlo, Secretary/Treasurer of the Dallas County Medical Society, P.O. Box 
4680 Dallas, TX 75208-0680 
4. Dr. Todd A. Pollock, Chairman of the Board of the Dallas County Medical Society, P.O. 
Box 4680 Dallas, TX 75208-0680 


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5. Dr. Bruce A. Meyer, Member of the Board of the Dallas County Medical Society, P.O. 
Box 4680 Dallas, TX 75208-0680 
6. Dr. Ruben L. Velez, Member of the Board of the Dallas County Medical Society, P.O. 
Box 4680 Dallas, TX 75208-0680 
7. Dr. Joseph J. Carlos, Member of the Board of the Dallas County Medical Society, P.O. 
Box 4680 Dallas, TX 75208-0680 
8.  Dr. Carlos E. Pancorvo, Member of the Board of the Dallas County Medical Society, 
P.O. Box 4680 Dallas, TX 75208-0680 
9. Dr. Alexandra Dresel, Member of the Board of the Dallas County Medical Society, P.O. 
Box 4680 Dallas, TX 75208-0680 
10. Dr. Thomas M. Zellers, Member of the Board of the Dallas County Medical Society, P.O. 
Box 4680 Dallas, TX 75208-0680 
11. Dr. R. Elizabeth Kassanoff, Member of the Board of the Dallas County Medical Society, 
P.O. Box 4680 Dallas, TX 75208-0680 
12. Dr. Kevin W. Klein, Member of the Board of the Dallas County Medical Society, P.O. 
Box 4680 Dallas, TX 75208-0680 
13. Dr. Clifford L. Simmang, Member of the Board of the Dallas County Medical Society, 
P.O. Box 4680 Dallas, TX 75208-0680 
14. Dr. Christopher Perkins, Medical Director of Dallas County Health and Human Services, 
2377 North Stemmons Freeway, Dallas, TX 75207-2710 
15. Zachary S. Thompson, Director of Dallas County Health and Human Services, 2377 
North Stemmons Freeway, Dallas, TX 75207-2710 
16. Dr. Shaina Drummond, Dallas County Anesthesiology Society, P.O. Box 36426, Dallas, 
TX 75235-1426 
17. Dr. Megan Way, Dallas County Anesthesiology Society, P.O. Box 36426, Dallas, TX 
75235-1426 
18. Dr. Daniel K. Podolsky, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, 
Dallas, TX 75390 
19. Dr. J. Gregory Fitz, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
20. Dr. Bruce A. Meyer, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
21. Dr. David Russell, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 
75390 
22. Dr. Milton Packer, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
23. Dr. H. Hunt Batjer, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
24. Dr. Kathleen R. Bell, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 


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25. Dr. Steven L. Bloom, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
26. Dr. Michael Choti, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
27. Dr. Hak Choy, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 
75390 
28. Dr. Deborah Diercks, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
29. Dr. Mark P. Goldberg, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, 
Dallas, TX 75390 
30. Dr. Michael E. Jessen, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
31. Dr. David H. Johnson, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
32. Dr. Jeffrey M. Kenkel, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, 
Dallas, TX 75390 
33. Dr. James S. Malter, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
34. Dr. Bradley Marple, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
35. Dr. James P. McCulley, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, 
Dallas, TX 75390 
36. Dr. Julio Perez Fontan, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, 
Dallas, TX 75390 
37. Dr. Claus G. Roehrborn, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, 
Dallas, TX 75390 
38. Dr. Neil M. Rofsky, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
39. Dr. Amer Shakil, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 
75390 
40. Dr. Adam Starr, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 
75390 
41. Dr. Carol A. Tamminga, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, 
Dallas, TX 75390 
42. Dr. Charles W. Whitten, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, 
Dallas, TX 75390 
43. Dr. Kim B. Yancey, UT-Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, 
TX 75390 
Spiritual and Religious Leadership 


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Page 56 of 68 
1. Bishop Michael McKee, North Texas Conference of the United Methodist Church, P.O. 
Box 866188, Plano, TX 75086-5014 
2. Rev. Dr. Sheron Patterson, North Texas Conference of the United Methodists Church, 
P.O. Box 866188, Plano, TX 75086-5014 
3. District Superintendent Camille Gaston, Metro District of the North Texas Conference of 
the United Methodist Church, 399 W. Campbell Road #200B, Richardson, TX 75080 
4. David Hardage, Executive Director, Baptist General Convention of Texas, 333 N. 
Washington Ave., Dallas, TX 75246 
5. Kathy Hillman, President, Baptist General Convention of Texas, 333 N. Washington 
Ave., Dallas, TX 75246 
6. Larry Vowell, Area Representative Director, Baptist General Convention of Texas, 333 
N. Washington Ave., Dallas, TX 75246 
7. Jim Pritchard, President, Southern Baptist Convention of Texas, 4500 State Highway 
360, Grapevine, TX 76051 
8. Sookwan Lee, Vice President, Southern Baptist Convention of Texas, 4500 State 
Highway 360, Grapevine, TX 76051 
9. Janet M. DeVries, General Presbyter, Grace Presbytery, 6100 Colwell Blvd Ste 100, 
Irving, TX 75039 
10. Gerry Tyer, Stated Clerk, Gracy Presbytery, 6100 Colwell Blvd, Ste 100, Irving, TX 
75039 
11. Michael Thompson, Associate General Presbyter, 6100 Colwell Blvd, Ste 100, Irving, 
TX 75039 
12. Rev. Douglas Anders, South Central Conference of the United Church of Christ, 9022 
Long Point Road, Houston, TX 77055 
13. Rev. Christine Ng, Senior Minister, Central Congregational Church, United Church of 
Christ, 5600 Royal Ln., Dallas, TX 75229 
14. Rev. Dr. Neil G. Cazares-Thomas, Senior Pastor, Cathedral of Hope of Dallas, United 
Church of Christ, 5910 Cedar Springs Rd., Dallas, TX 75235-6806 
15. Bishop Paul E. Lambert, Episcopal Diocese of Dallas, 1630 N. Garrett Ave., Dallas, TX 
75206 
16. Bishop-Elect George Sumner, Episcopal Diocese of Dallas, 1630 N. Garrett Ave., Dallas, 
TX 75206 
17. Rev. Ken Hennings, President, the Texas District of the Lutheran Church-Missouri 
Synod, 7900 East Highway 290, Austin, TX 78724 
18. Executive Director, North Texas District Council of the Assembly of God, Waxahachie, 
TX 75167 
19. Pastor Billy E. Wright, Southwest Region Conference, Seventh-Day Adventists, 2215 
Lanark Ave, Dallas, TX 75203-4528 
20. Church of Jesus Christ of Latter-day Saints 


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21. Most Reverend Kevin J. Farrell, D.D., Bishop of Dallas, 3725 Blackburn Street, Dallas, 
TX 75219 
22. Most Reverend J. Douglas Deshotel, Auxiliary Bishop, Diocese of Dallas, 3725 
Blackburn Street, Dallas, TX 75219  
23. Rabbi William Gershon, Congregation Shearith Israel, 9401 Douglas Ave, Dallas, TX 
75225 
24. Rabbi David Stern, Temple Emanuel, 8500 Hilcrest Rd., Dallas, TX 75225 
25. Islamic Association of North Texas, Dallas Central Mosque, 840 Abrams Rd., 
Richardson, TX 75081 
26. Council on American Islamic Relations, 2904 Floyd St., Suite B., Dallas, TX 75204 
27. David Boyd Larsen, Stake President of the Dallas Stake of the Church of Jesus Christ of 
Latter-Day Saints, 6363 Willow Lane, Dallas, TX 75230-2227 
28. Rev. Daniel Kanter, Senior Minister, First Unitarian Church of Dallas, 4015 Normandy 
Avenue, Dallas, TX 75205-1750 
29. Rev. Mark Walz, Unitarian Universalist Church of Oak Cliff, 3839 W. Kiest Blvd., 
Dallas, TX 75233 
30. Swati Pandit, DFW Hindu Temple Society, 1605 N. Britain Rd., Irving, TX 75061 
31. Santhi Kumar, President, Sri Ganesha Temple, 6508 K-Avenue, Plano, TX 75074 
32. Gopala Pillai, President, Sri Guruvayurappan Temple of Dallas, 1701 Spring Valley Ln, 
Carrollton, TX 75006 
33. Manmohan Singh, Chairman, Sikh Temple of North Texas, 506 Gatewood Dr, Garland, 
TX 75043 
34. Gurdwara Nishkam Seva, 834 N. Nursery Rd., Irving, TX 75061 
35. Church Leader, The Buddhist Center of Dallas, 8484 Stults Rd., Dallas, TX 75243 
36. Church Leader, Jehovah’s Witnesses Church, 5308 W. Mockingbird Ln., Dallas, TX 
75209 
37. Dr. Tim Gorski, North Texas Church of Freethought, 1001 N Waldrop Drive #815, 
Arlington TX 76012 
38. Randy Word, Metroplex Atheists, P.O. Box 121818, Arlington, TX 76012 
39. Trinity Native American Church, 208 South Haskell, Dallas, TX 75206 
 
Community Organizations 
1. Dr. Juanita Wallace, President of Dallas NAACP, P.O. Box 131768, Dallas, TX 75313 
2. Kenneth Green, 1st Vice President of Dallas NAACP, P.O. Box 131768, Dallas, TX 
75313 
3. Doris Hart, 2nd Vice President of Dallas NAACP, P.O. Box 131768, Dallas, TX 75313 
4. Linda Lydia, Executive Committee Chair for Health, Dallas NAACP, P.O. Box 131768, 
Dallas, TX 75313 
5. YMCA of Metropolitan Dallas, Association Office, 1621 W. Walnut Hill Ln., Irving, TX 
75038 


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6. YMCA of Metropolitan Dallas, President’s Office, 601 N. Akard St, Dallas, TX 75201 
7. DFW International Community Alliance (representing multiple community organizations 
listed at www.dfwinternational.org), President’s Office, 9064 Stone Creek Place, Dallas, 
TX 75243 
8. Great Dallas Hispanic Chamber of Commerce, President’s Office, 3700 Ross Avenue, 
Dallas, TX 75204 
9. Dallas Regional Chamber of Commerce, President’s Office, 500 N Akard St #2600, 
Dallas, TX 75201 
10. Latino Dallas at the Dallas Convention & Visitors Bureau, 325 N St. Paul Street, Suite 
700, Dallas, TX 75201 
11. The Concilio, President Florencia Velasco Fortner, 400 South Zang Blvd, Suite 300, 
Dallas, TX 75208 
12. Korean Association-North Texas, 11445 Emerald St #111 Dallas, TX 75229 
13. DFW Asian-American Citizens Council, 420 Maplelawn Drive, Plano, TX 75075 
14. Dallas AARP, 8140 Walnut Hill Ln #108, Dallas, TX 75231 
 
Organizations Providing Emergency Social Services and Shelter 
1. Dallas LGBT Resource Center, President’s Office, 2701 Reagan St., Dallas, TX 75219 
2. RSVP, Dallas Senior Citizen Center, 3910 Harry Hines Blvd, Dallas, TX 75219 
3. Dallas Life Foundation, 1100 Cadiz St, Dallas, TX 75215 
4. The Bridge Homeless Recovery Center, 1818 Corsicana St, Dallas, TX, 75201 
5. Family Gateway Inc, 711 South St. Paul St., Dallas, TX 75201 
6. Teena’s Place, 7728 Los Gatos Dr., Dallas, TX 75232 
7. Shared Housing Center Inc, 402 N Good Latimer Expy, Dallas, TX 75204 
8. Union Gospel Mission, 3211 Irving Blvd, Dallas, TX 75247 
9. Genesis Women’s Shelter – Outreach, 4411 Lemmon Ave #201, Dallas TX  
10. The Stewpot, 1835 Young St., Dallas, TX 75201 
11. Shelter Ministries of Dallas, 2929 Hickory St., Dallas, TX 75226 
12. Austin Street Shelter, 2929 Hickory St., Dallas, TX 75226 
13. MDHA, 904 S. Ervay St., Dallas, TX 75201 
14. The Salvation Army, 5554 Harry Hines Blvd, Dallas, TX 75235 
15. The Salvation Army, 6500 Harry Hines Blvd, Dallas, TX 75235 
16. The Salvation Army, 1617 W Jefferson Blvd, Dallas, TX 75208 
17. The Salvation Army, 939 W. Jefferson Blvd, Dallas, TX 75208 
18. The Salvation Army, 1007 Hutchins Rd, Dallas, TX 75203 
19. The Salvation Army, 8341 Elam Rd., Dallas, TX 75217 
20. The Salvation Army, 4810 Village Fair Drive, Dallas, TX 75224 
21. The Salvation Army, 8787 N Stemmons Freeway, Dallas, TX 75247 
22. The Salvation Army, 1145 E Irving Blvd, Irving, TX 75060 
23. The Salvation Army, 250 E Grauwyler Rd., Irving, TX 75061 


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24. The Salvation Army, 12895 Josey Ln, Farmers Branch, TX 75234 
25. The Salvation Army, 1418 W Buckingham Rd, Garland, TX 75040 
26. The Salvation Army, 451 W Avenue D, Garland, TX 75040 
27. The Salvation Army, 1301 E Abram St., Arlington, TX 76010  
Local Homeowners Associations 
1. Prestonwood Homeowners Association, Inc. PO Box 795682, Dallas TX 75379 
2. Dallas Homeowners League, 7143 Fisher Rd, Dallas, TX 75214 
3. Dallas Homeowners League, PO Box 600845, Dallas TX 75360 
4. Oaks HOA, 6646 E. Lovers Ln, Dallas TX 75214 
5. Mountain Creek Homeowners Association, 3402 S Belt Line Rd, Grand Prairie, TX 
75052 
6. Oak Tree Estates Homeowners Association, 5227 Frankford Rd, Dallas, TX 75287 
7. Deerchase Homeowners Association, 611 Oriole Blvd, Duncanville, TX 75116 
8. North Dallas Neighborhood Alliance, President Matt Bach, www.ndna-tx.org 
 
Local Hospitals 
1. Medical City Dallas Hospital, 7777 Forest Ln, Dallas, TX 75230 
2. Texas Health Presbyterian Hospital, 8200 Walnut Hill Ln., Dallas, TX 75231 
3. Methodist Dallas Medical Center, 1441 N Beckley Ave, Dallas, TX 75203 
4. Baylor University Medical Center at Dallas, 3500 Gaston Ave, Dallas, TX 75246 
5. LifeCare Hospitals of Dallas, 1950 Record Crossing Rd, Dallas, TX 75246 
 
Nursing Homes and Associations 
1. Texas Health Care Association, 4214 Medical Pkwy #300, Austin TX 78756 
2. Grace Presbyterian Village, 550 E Ann Arbor Ave, Dallas, TX 75216 
3. Walnut Place, 5515 Glen Lakes Dr, Dallas, TX 75231 
4. Legacy at Preston Hollow, 11409 N Central Expy, Dallas, TX 75243 
5. Treemont Dallas, 5550 Harvest Hill Rd, Dallas, TX 75230 
6. Presbyterian Village North, 8600 Skyline Dr, Dallas, TX 75243 
7. South Dallas Nursing Home, 3808 S Central Expy, Dallas TX 75215 
8. Senior Care Health & Rehabilitation, 2815 Martin Luther King Jr. Blvd, Dallas, TX 
75215 
9. Pearl Nordan Care Center, 1260 Abrams Rd., Dallas, TX 75214 
10. Juliette Fowler Communities, 1234 Abrahams Rd., Dallas, TX 75214 
11. Buckner Retirement Village, 4800 Samuell Blvd., Dallas, TX 75228 
12. The Forum at Park Lane, 7831 Park Ln, Dallas TX 75225 
13. Golden Acres Living & Rehabilitation, 2525 Centerville Rd, Dallas, TX 75228 
14. Edgemere Retirement Communities, 8523 Thackery St, Dallas, TX 75225 
15. Villages of Lake Highland, 8615 Lullwater Dr., Dallas, TX 75238 
16. Traymore Nursing Center, 4315 Hopkins Ave, Dallas, TX 75209 


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17. Brentwood Place One, 8069 Scyene Circle, Dallas, TX 75227 
18. Southhaven Nursing Center, 5300 Houston School Rd, Dallas, TX 75241 
19. Highland Springs, 8000 Frankford Rd, Dallas, TX 75252 
20. The Bentley, 3362 Forest Ln, Dallas TX 75234 
21. Avalon Memory Care, 1625 N Stemmons Fwy, Dallas, TX 75702 
22. Ashford Hall Long Term Care, 2021 Shoaf Dr., Irving, TX 75061 
23. Balch Springs Nursing Home, 4200 Shepherd Ln, Balch Springs, TX 75180 
24. Christian Care Center, 1000 Wiggins Pkwy, Mesquite, TX 75150 
25. Silverado Turtle Creek Memory Care Community, 3611 Dickason Ave, Dallas, TX 
75219 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 9: Draft Outreach Letter to Community Leaders (English/Spanish) 
 
Dear (Community Leader), 
 
I am one of the physicians at Parkland Memorial Hospital and UT-Southwestern Medical Center in Dallas, TX. The 
purpose of this letter is to inform you of an upcoming clinical research trial known as “Etomidate versus ketamine 
for emergency endotracheal intubation: a prospective randomized clinical trial (the EvK Trial).”  This clinical trial 
will be done at Parkland Memorial Hospital, starting in 2016.  
 
Why am I notifying you about this study?  
 
The EvK Clinical Trial is a study of how to best take care of patients who require an emergency placement of a 
breathing tube. The purpose of the EvK Trial is to help us understand better which medication – etomidate or 
ketamine – is better for patients during this procedure. Because we are studying an emergency condition, it is not 
practical to obtain written informed consent prior to study enrollment. The U.S. Food and Drug Administration 
(FDA) requires that I notify community leaders, and the community broadly, before starting this type of study. 
These regulations are outlined in FDA 21 CFR 50.24. Our study is discussed in detail on our website, 
www.evkclinicaltrial.org, and is also registered on www.clinicaltrials.gov. 
 
I would like to invite you, or your representative(s), to one of our community outreach meetings, listed below. 
Alternately I would be happy to speak with you in person, by phone, or by mail at one of the contact numbers listed 
above. The goal of these meetings is to answer any questions or concerns you might have about this study, and to 
ask for feedback. 
 
Most sincerely yours,  
 
Gerald Matchett, MD 
Principal Investigator of the EvK Trial 
 
Schedule for Public Meetings about the EvK Trial 
 
Community Leader Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to all community leaders and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org 
 
Open Community Meeting 
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to all community members and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org 
 
Open Community Meeting 
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to all community members and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org 
 
Clinical Trial Contact Information 
Telephone hotline: 214-TBD-TTBD 
Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-Southwestern Medical Center 
MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-9068 
Email: tbd@evkclinicaltrial.org 
Web-Site:www.evkclinicaltrial.org  
 
 
 


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Appendix 10: Draft EvK Trial Website (English/Spanish) 
 
Etomidate versus Ketamine for Emergency Endotracheal Intubation: A prospective 
randomized clinical trial (the EvK Trial) 
 
Brief Summary 
Patients who are having problems breathing sometimes require placement of a breathing tube in their mouth and 
windpipe. The purpose of this breathing tube is to save the patient’s life. It is common to give the patient a 
medication to sedate him or her before the breathing tube is placed. For patients who are gravely ill two medications 
are commonly used: etmoidate or ketamine. Both medications have risks and benefits. We would like to do a study 
to figure out which one is better for our patients. 
 
Detailed Summary 
Critically ill individuals who require emergency endotracheal intubation (placement of a breathing tube in the 
patient’s mouth) usually require sedation or anesthesia to make this process tolerable. There are several medication 
choices for anesthesia, including medications like etomidate, ketamine and propofol. Of these, etomidate and 
ketamine are frequently used for critically ill patients because they have minimal effects on the patient’s vital signs 
(blood pressure and heart rate). Both etomidate and ketamine are standard-of-care medications, locally and 
nationally, and both are frequently used to sedate a patient for this procedure. Both etomidate and ketamine have 
side effects. One of the side effects of etomidate is that is suppresses the function of the adrenal glands. It is not 
known if this affects the patient’s outcome in a significant way. Ketamine has other side effects, such as slightly 
increasing the patient’s heart rate. It is not known if this affects the patient’s outcome in a significant way.   
 
The EvK Trial will be conducted at Parkland Memorial Hospital by investigators in the Departments of 
Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, Surgery, and Pharmacy. The study will 
randomize critically ill patients who require emergency endotracheal intubation to one of two groups: Etomidate or 
Ketamine. We will observe the patients’ outcomes. The only study intervention involves randomizing individual 
patients to one medication or the other. All study follow-up beyond that point is done by review of medical records.  
 
Because of the nature of this study – an emergency procedure on a critically ill patient – the study will require 
formal permission to bypass pre-enrollment written informed consent. The purpose of this website is to notify the 
public of this research project, in accordance with rules set forth by the U.S. Food and Drug Administration (FDA 
21 CFR 50.24). 
 
Study Contact Methods 
A. Telephone hotline and opt-out: 214-TBD-TTBD 
B. Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-Southwestern 
Medical Center MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-9068 
C. Email: tbd@evkclinicaltrial.org 
D. Web-Site (online feedback form): www.evkclinicaltrial.org (or similar, yet to be established). 
Link to study registration at www.clinicaltrials.gov 
 
Links to Institutions 
(Parkland Memorial Hospital Link) 
(UT-Southwestern Medical Center Link) 
(Dept. of Anesthesiology Link) 
(Dept. of Medicine / CCM Link) 
(Dept. of ED Link) 
(Dept. of Surgery Link) 
(Link to Parkland Memorial Hospital CRO) 
(Link to UT-Southwestern  IRB) 
 
Link to Principal Investigator 


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http://profiles.utsouthwestern.edu/profile/120396/gerald-matchett.html 
 
Links to FAQ’s 
1. Are etomidate and ketamine used frequently for emergency endotracheal intubation? 
Yes. Both are commonly used, and both are the “standard-of-care” locally and nationally. 
2. If both etomidate and ketamine are frequently used for this procedure, why are you doing the study? 
There is considerable debate right now regarding which medication is better for patients. Each medication 
has side effects.  
3. What does it mean to “randomize” a patient? 
This means that individual patients who are enrolled in the study will receive either etomidate or ketamine. 
Which medication they will receive will depend on random chance, similar to what happens with a coin 
toss. 
4. Besides receiving etomidate or ketamine, will patients in the study have any other study-related 
procedures? 
No. The only intervention for the study is the choice of etomidate or ketamine, which will be done by 
random selection. Data will be gathered from the patient’s medical record after they enter the study, but this 
will not have any effect on medical care. 
5. Why won’t patients have a chance to sign a consent form before enrolling in the study? 
The EvK Trial is a study of an emergency medical procedure. The patients who are eligible for the study 
are critically ill and require immediate medical care (placement of a breathing tube), and therefore cannot 
give informed consent. After a patient is enrolled in the study, the study team will notify the patient and / or 
family of study enrollment, in accordance with FDA rules governing emergency medical research (FDA 21 
CFR 50.24). 
6. Is it legal to do a research study on a patient before he or she give written informed consent? 
Yes, provided the study complies with the regulations governing this type of research. The U.S. Food and 
Drug Administration (FDA) has determined that in select cases of emergency research it is acceptable to do 
research without first obtaining written informed consent. Information about this can be obtained at the 
FDA website (linked here).  
7. Who is eligible to enroll in the study? Can patients volunteer for the study? 
The EvK Trial will enroll patients who are critically ill, and specifically those who require emergency 
placement of a breathing tube. These patients are typically found in an emergency department, or intensive 
care unit, who are there under emergency circumstances. Because of this, individuals cannot volunteer for 
this study. 
8. How will the public be notified about the EvK Trial? 
The U.S. Food and Drug Administration (FDA) requires that several specific measures be taken for 
research in emergency medical conditions. These measures are described in FDA 21 CFR 50.24, and 
include things like (A) A meeting with community leaders and (B) Outreach to the community at-large. 
The EvK Trial investigators have a comprehensive Community Outreach Plan that meets these 
requirements, and includes direct outreach to community leaders, media outreach, community outreach by 
meetings, and internet advertising and a study website (www.evkclinicaltrial.org). 
9. How many patients will enroll in the study? 
Approximately 750 patients will enroll.  
10. Will the study investigators make money off the results of this study? 
No. The EvK Trial collaborators do not have a financial stake in the outcome of the study. The study is 
primarily funded by the University of Texas-Southwestern Medical Center. Both medications used in the 
EvK Trial (etomidate and ketamine) are generic medications, and the study is not being done to market 
either medication. The EvK Trial is not a “for profit” study. No drug companies, or their agents or 
representatives, were involved in the design of this study, and none will be involved in the conduct of the 
study. Patients will not be billed or charged for study-related activities. 


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11. How do I contact the research team if I have questions or concerns? 
E. Telephone hotline and opt-out: 214-TBD-TTBD 
F. Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-Southwestern 
Medical Center MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-9068 
G. Email: tbd@evkclinicaltrial.org 
H. Web-Site (online feedback form): www.evkclinicaltrial.org (or similar, yet to be established). 
12. I would like to formally “opt-out” of the study. How do I do that?  
Individuals who live in the catchment area of Parkland Memorial Hospital in Dallas, TX may “opt-out” of 
the study. To do this, please request to opt-out using the contact information above. You will be sent a 
custom MedAlert bracelet indicating this choice. The bracelet will be sent to you free of charge by mail.  
13. When and where are the community meetings?  
Community Leader Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to all community leaders and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
Open Community Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to the general public and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
Open Community Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to the general public and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
14. Is this study approved by an Institutional Review Board (IRB)? 
The IRB has reviewed the study, and has given us permission to begin the Community Notification Plan. 
The results of that plan will be reviewed by the IRB once the plan is completed. At that point the IRB may, 
or may not, permit us to begin enrolling patients.  
15. How long will this clinical trial take? 
Approximately 2-3 years 
16. Will the results of this research be announced? 
Yes. Results will be announced publically through various methods, including publication in a scientific 
journal. No Protected Health Information (PHI) will be published or publically disclosed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


CONFIDENTIAL – NOT FOR DISTRIBUTION 
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Appendix 11: Draft Print Advertisements in Dallas Morning News and Al Dia Dallas 
 
Announcing a New Clinical Trial at Parkland Memorial Hospital: 
 
“Etomidate versus ketamine for emergency endotracheal intubation: a prospective randomized clinical trial (the EvK 
Trial)” 
 
This clinical trial will be conducted at Parkland Memorial Hospital starting in 2016. In this trial we will study which 
medication (etomidate or ketamine) is better for patients who require emergency placement of a breathing tube in 
their mouth. Because the study is being done without pre-enrollment written informed consent, FDA 21 CFR 50.24 
requires public notification and feedback.  
 
For more information: 
 
Community Leader Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to all community leaders and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
Open Community Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to the general public and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
Open Community Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open the general public and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
Clinical Trial Contact Information 
Telephone hotline: 214-TBD-TTBD 
Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-Southwestern Medical Center 
MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-9068 
Email: tbd@evkclinicaltrial.org 
Web-Site:www.evkclinicaltrial.org  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 12: Draft Poster / Flyer Advertisement (English/Spanish) 
 
The EvK Clinical Trial 
at Parkland Memorial Hospital  
 
More Information: 
 
 
The EvK Clinical Trial is a study of how to best take care of patients who require an emergency placement of a 
breathing tube. The purpose of the EvK Trial is to help us understand better which medication – etomidate or 
ketamine – is better for patients during this procedure. The full title of the study is “Etomidate versus ketamine for 
emergency endotracheal intubation: A prospective randomized clinical trial.” 
 
Because we are studying an emergency condition, it is not practical to obtain written informed consent prior to study 
enrollment. The U.S. Food and Drug Administration (FDA) requires notification of community leaders, and the 
community broadly, before starting this type of study.  
 
Community Leader Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to all community leaders and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
Open Community Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open to the general public and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
Open Community Meeting  
Month, Date, Year, Room X, Parkland Memorial Hospital, X PM 
Open the general public and news media. Translator services available. 
Please RSVP to XYZ@evkclinicaltrial.org, or 214-TBD-TTBD 
 
Clinical Trial Contact Information 
Telephone hotline: 214-TBD-TTBD 
Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-Southwestern Medical Center 
MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-9068 
Email: tbd@evkclinicaltrial.org 
Web-Site:www.evkclinicaltrial.org  
 
 
 
 
 
 
 
 


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Appendix 13: Draft Notice of Enrollment Letter (English/Spanish) 
 
Dear (Enrolled Patient), 
 
I am one of the researchers at UT-Southwestern Medical Center and Parkland Memorial Hospital in Dallas, TX. The 
purpose of this letter is to inform you that you were enrolled in a clinical trial during a recent hospitalization. The 
trial is known as “Etomidate versus ketamine for emergency endotracheal intubation: A prospective randomized 
clinical trial (The EvK Trial),” Institutional Review Board #STU022015-023.  
 
In this clinical trial you received one of two medications during your medical or surgical care: etomidate or 
ketamine. These medications were used to help sedate you while a breathing tube was placed in your mouth. The 
purpose of the trial is to evaluate which medication (ketamine or etomidate) is associated with better outcomes 
following placement of a breathing tube. The clinical trial has no effect on medical care after the initial choice of 
medication. Both of the medications in the trial are commonly used for this procedure, both are approved by the U.S. 
Food and Drug Administration (FDA), and both are considered the “standard of care.” Neither medication is 
considered experimental. 
 
For this clinical trial my co-investigators and I obtained special permission from the Institutional Review Board to 
enroll patients prior to obtaining written consent. My co-investigators and I are obligated to inform you of the 
enrollment in person, by telephone or mail. My co-investigators and I would welcome the opportunity to speak with 
you or your family about this research trial. We would also like to ask permission to use your anonymous clinical 
data as part of the study. You have no obligations to contact us if you do not wish to do so. If you wish to contact 
me, please feel free to use any of the avenues listed below. 
 
Most sincerely yours, 
 
Gerald Matchett, MD 
Principal Investigator 
EvK Clinical Trial 
 
 
Clinical Trial Contact Information 
Telephone hotline: 214-TBD-TTBD 
Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-Southwestern Medical Center 
MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-9068 
Email: tbd@evkclinicaltrial.org 
Web-Site:www.evkclinicaltrial.org  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 14: Draft Notice of Enrollment Letter (English/Spanish) to Family / Next-of-Kin 
 
Dear (Family and/or Next-of-Kin of Enrolled Patient) 
 
I am one of the researchers at Parkland Memorial Hospital and UT-Southwestern Medical Center in Dallas, TX. The 
purpose of this letter is to inform you that your family member was recently enrolled in a clinical trial during his/her 
recent hospitalization. The trial is known as “Etomidate versus ketamine for emergency endotracheal intubation: A 
prospective randomized clinical trial (The EvK Trial),” Institutional Review Board #STU022015-023.  
 
In this clinical trial your family member received one of two medications during the course of medical or surgical 
care: etomidate or ketamine. These medications were used to help sedate a patient while a breathing tube was placed 
in his or her mouth. The purpose of the trial is to evaluate which medication (ketamine or etomidate) is associated 
with better outcomes following placement of a breathing tube. The clinical trial has no effect on medical care after 
the initial choice of medication. Both of the medications in the trial are commonly used for this procedure, both are 
approved by the U.S. Food and Drug Administration (FDA), and both are considered the “standard of care.” Neither 
medication is considered experimental. 
 
For this clinical trial my co-investigators and I obtained special permission from the Institutional Review Board to 
enroll patients prior to obtaining written consent. My co-investigators and I are obligated to inform you of the 
enrollment in person, by telephone or mail. My co-investigators and I would welcome the opportunity to speak with 
you or your family about this research trial. We would also like to ask permission to use your relative’s anonymous 
clinical data as part of the study. You have no obligations to contact us if you do not wish to do so. If you wish to 
contact me, please feel free to use any of the avenues listed below. 
 
Most sincerely yours, 
 
Gerald Matchett, MD 
Principal Investigator 
EvK Clinical Trial 
 
 
Clinical Trial Contact Information 
Telephone hotline: 214-TBD-TTBD 
Standard Mail: Dept. of Anesthesiology & Pain Management, University of Texas-Southwestern Medical Center 
MC 9068, 5323 Harry Hines Blvd, Dallas, TX 75390-9068 
Email: tbd@evkclinicaltrial.org 
Web-Site:www.evkclinicaltrial.org