Improving Safety and Quality of Tracheal Intubations in Neonatal ICUs
Phase: NA
Conditions: Failed or Difficult Intubation, Sequela, Intubation;Difficult, Intubation Complication
Sponsor: Children's Hospital of Philadelphia

 
Template version: May 28, 2014 
PROTOCOL TEMPLATE: INTERVENTION STUDY (CLINICAL TRIALS) 
  
Title: 
Improving safety and quality of tracheal intubations in 
neonatal ICUs 
Short Title 
Tracheal intubation coaching in NICUs 
Drug or Device 
Name(s): 
Video laryngoscope 
FDA IND: 
Not applicable 
Regulatory Sponsor: 
 
eIRB Number: 
 
Protocol Date: 
February 16, 2017 
 
Amendment 1 Date: January 10, 2018 
Amendment 3 Date: March 1, 2018 
Amendment 2 Date: February 21, 2018 
Amendment 4 Date: June 26, 2018 
 
Study Principal Investigator  
 
Akira Nishisaki, MD, MSCE 
Main Building, 8NW Suite 8566 
The Children’s Hospital of Philadelphia 
Philadelphia, PA, 19104 
Phone 215-590-5505 
email: nishisaki@chop.edu 
 

 
 
 
 
 
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms............................................................................. iv 
Abstract .................................................................................................................................. v 
Protocol Synopsis ................................................................................................................. vii 
Table 1: Schedule of Study Procedures ............................................................................... x 
1 BACKGROUND INFORMATION AND RATIONALE ............................................. 1 
1.1 INTRODUCTION ............................................................................................................. 1 
1.2 NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION .............. 1 
1.3 FINDINGS FROM NON-CLINICAL AND CLINICAL STUDIES.............................................. 1 
1.3.1 Clinical Studies in Adults………………………………………………………………..1 
1.3.2 Clinical Studies in Children .................................... Error! Bookmark not defined. 
1.4 RELEVANT LITERATURE AND DATA .............................................................................. 2 
1.5 COMPLIANCE STATEMENT ............................................................................................ 2 
2 STUDY OBJECTIVES .................................................................................................... 2 
2.1 PRIMARY OBJECTIVE (OR AIM) ..................................................................................... 2 
2.2 SECONDARY OBJECTIVES (OR AIM) .............................................................................. 3 
3 INVESTIGATIONAL PLAN.......................................................................................... 3 
3.1 GENERAL SCHEMA OF STUDY DESIGN .......................................................................... 3 
3.1.1 Screening Phase ..................................................................................................... 3 
3.1.2 Study Treatment Phase (start of the study intervention) ....................................... 3 
3.1.3 Transition Phase .................................................................................................... 3 
3.1.4 Follow-up Phase .................................................................................................... 3 
3.2 ALLOCATION TO TREATMENT GROUPS AND BLINDING ................................................. 3 
3.3 STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ............................................ 4 
3.3.1 Duration of Study Participation ............................................................................ 4 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected ........................ 4 
3.4 STUDY POPULATION ..................................................................................................... 4 
3.4.1 Inclusion Criteria ................................................................................................... 4 
3.4.2 Exclusion Criteria .................................................................................................. 5 
4 STUDY PROCEDURES.................................................................................................. 5 
4.1 SCREENING/INITIAL TRAINING VISIT .............................................................................. 5 
4.2 FOLLOW UP PHASE ......................................................................................................... 5 
4.2.1 Visit 1 ..................................................................................................................... 5 
4.3 SUBJECT COMPLETION/WITHDRAWAL .......................................................................... 6 
5 STUDY EVALUATIONS AND MEASUREMENTS ................................................... 6 
5.1 SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ........................... 6 
5.1.1 Physical Examination ............................................................................................ 6 
5.1.2 Other Evaluations, Measures ................................................................................ 6 
5.2 EFFICACY EVALUATIONS .............................................................................................. 7 

 
 
 
 
 
 
 
 
 
 
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5.2.1 Diagnostic Tests, Scales, Measures, etc. ............................................................... 7 
5.3 SAFETY EVALUATION ................................................................................................... 7 
6 STATISTICAL CONSIDERATIONS ........................................................................... 8 
6.1 PRIMARY ENDPOINT ..................................................................................................... 8 
6.2 STATISTICAL METHODS ................................................................................................ 8 
6.2.1 Baseline Data ......................................................................................................... 8 
6.2.2 Efficacy Analysis .................................................................................................... 8 
6.2.3 Safety Analysis ....................................................................................................... 8 
6.3 SAMPLE SIZE AND POWER ............................................................................................. 8 
6.4 INTERIM ANALYSIS ....................................................................................................... 9 
7 SAFETY MANAGEMENT ............................................................................................. 9 
7.1 CLINICAL ADVERSE EVENTS ......................................................................................... 9 
7.2 ADVERSE EVENT REPORTING ....................................................................................... 9 
8 STUDY ADMINISTRATION ......................................................................................... 9 
8.1 TREATMENT ASSIGNMENT METHODS ........................................................................... 9 
8.1.1 Randomization ....................................................................................................... 9 
8.2 DATA COLLECTION AND MANAGEMENT ..................................................................... 10 
8.3 CONFIDENTIALITY ...................................................................................................... 10 
8.4 REGULATORY AND ETHICAL CONSIDERATIONS .......................................................... 10 
8.4.1 Risk Assessment ................................................................................................... 10 
8.4.2 Potential Benefits of Trial Participation ............................................................. 11 
8.4.3 Risk-Benefit Assessment ....................................................................................... 11 
8.5 RECRUITMENT STRATEGY ........................................................................................... 11 
8.6 INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ..................................... 12 
8.6.1 Waiver of Consent ................................................................................................ 12 
8.6.2 Waiver of Assent ................................................................................................ 122 
8.6.3 Waiver of HIPAA Authorization ........................................................................ 122 
8.7 PAYMENT TO SUBJECTS/FAMILIES .............................................................................. 12 
8.7.1 Gifts .................................................................................................................... 122 
9 
PUBLICATION ............................................................................................................ 12 
10 REFERENCES ............................................................................................................. 13 
APPENDIX I……………………………………………………………………………….14 
APPENDIX II………………………………………………………………………………15 
  

 
 
 
 
 
 
 
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
TI 
 
Tracheal Intubation 
NICUs 
 
Neonatal Intensive Care Units 
VL 
 
Video Laryngoscopy 
NEAR4KIDS 
 
National Emergency Airway Registry for Kids 
TIAE 
 
Tracheal Intubation Associated Event 
DCC 
 
Data Coordinating Center 
NIH 
 
National Institute of Health 
AE 
 
Adverse Event 
SAE 
 
Severe Adverse Event 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
v
ABSTRACT 
Context:  (Background) 
Tracheal intubation (TI) is the most common life-saving intervention for resuscitation and 
stabilization of critically ill neonates in Neonatal Intensive Care Units (NICUs). 
Recently, video laryngoscopy (VL) has become available in neonatal clinical practice to 
allows trainees and frontline providers to perform standard direct airway visualization (i.e., 
traditional laryngoscopy) while the supervisor can simultaneously view a real-time video 
displaying what the laryngoscopist is seeing. However, VL associated coaching during TI 
has not been rigorously evaluated. 
Objectives: (primary and important secondary objectives) 
To determine if a video laryngoscope assisted real-time coaching intervention can reduce 
adverse TI associated events and desaturation across academic NICUs. 
Study Design:  
A quasi-experimental before-after design with educational quality improvement 
interventions at multiple NICUs with randomly staggered timing for educational 
intervention (as known as stepped-wedge design) based on the NICU characteristics.  
Setting/Participants: 
Neonatal ICUs in academic centers across the United States and Canada.  
Approximately 10 NICU sites with up to 24 faculty at each site (up to 240 faculty,senior 
nurse practitioners, physician assistants and respiratory therapists with at least 5 years of 
clinical neonatology experience).  
Approximately 1800 trainees and frontline providers who are qualified to perform tracheal 
intubation under attendings supervision. 
Study Interventions and Measures:  
Study intervention is a VL coaching training for site neonatology attendings,nurse 
practitioners, physician assistants, and respiratory therapists. Each site leader/key educator 
will be trained remotely by expert co-investigators.  Site leaders and key educators will train 
their attendings, NPs, Pas, and RTs. The quality of VL coaching skills will be verified by 
randomly auditing 20% of attending providers, NPs, PAs, and RTsat each site for their skill 
assessment by remote simulation during the transition/post-intervention phase. The timing of 
VL coaching implementation will be randomly staggered between 6-12 months.  
The primary endpoint is the occurrence of adverse tracheal intubation associated events in 
primary intubations in NICUs. These data points are recorded through the existing 
observational registry study: NEAR4KIDS CHOP IRB number 09-007253.  

 
 
 
 
 
 
 
 
 
 
vi
The secondary endpoint is the successful completion of all faculty staff training at 
participating sites, and their performance in the follow up skill evaluation using audio-
recording as well as the change in the occurrence of severe oxygen desaturation (absolute 
oxygen saturation drop >20% from baseline) across 10 academic NICUs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
vii
PROTOCOL SYNOPSIS 
Study Title 
Improving safety and quality of tracheal intubations in neonatal 
ICUs 
Funder 
National Institutes of Health (NIH) 
Clinical Phase 
Not applicable 
Study Rationale 
Tracheal intubation (TI) is the most common life-saving 
intervention for resuscitation and stabilization of critically ill 
neonates in Neonatal Intensive Care Units (NICUs). More than 
400,000 neonates are admitted to NICUs in the US annually, and 
10%-15% of these infants (>40,000) require TI to sustain life. TI 
procedures are high risk. Adverse TI associated events are frequent 
(20%) and severe desaturation during TI (>20% absolute decrease in 
oxygen saturation) occurs in >50%. Neonatal TIs have unique risks 
related to difficult airway anatomy (e.g., anterior larynx) and 
physiology (e.g. limited pulmonary oxygen reserve) requiring 
prompt procedural success. Provider technical skills, suboptimal TI 
approach such as underuse of neuromuscular blockade, and 
communication errors contribute to neonatal TI risks.  
Previous TI studies indicate that training level and multiple attempts 
are associated with adverse TI associated events and severe 
desaturation. Video laryngoscopy (VL) is now available in neonatal 
practice, but standard direct laryngoscopy technique for TI remains 
a core clinical skill. Newer VL technology allows trainees and 
frontline providers to perform standard traditional laryngoscopy 
while their supervisor can simultaneously view a real time video 
display of what the trainee/laryngoscopist is actually seeing. This 
technology enables expert “coaching” by a supervisor for the 
hazardous TI procedure. 
Study Objective(s) 
Primary  
 
To determine if a novel video laryngoscope assisted real-time 
coaching intervention can reduce adverse TI associated events 
across approximately 10 academic NICUs 
Secondary 
 
To determine if a novel video laryngoscope assisted real-time 
coaching intervention can reduce severe oxygen desaturation 
(absolute oxygen saturation drop >20% from baseline) across 10 
academic NICUs 
 
To determine duration till completion of faculty training and 
evaluate faculty performance during transition/post-intervention 
phase 

 
 
 
 
 
 
 
 
 
 
viii
Study Design 
 
A quasi-experimental before-after design with educational quality 
improvement interventions. 
Subject Population 
key criteria for 
Inclusion and Exclusion: 
Inclusion Criteria 
 
Subjects age 22-above 
 
VL coach: Neonatology attending physician position at each 
neonatal ICU, or Senior trainees who are anticipated to graduate 
within next 6 months to become neonatology attending 
physicians, nurse practitioners with over 5 years of clinical 
experience, physician assistants and respiratory therapists with 
over 5 years of clinical neonatology experience.  
 
VL coach receivers: Trainees (medical students, residents, 
fellows except those graduating within next 6 months) and 
frontline providers (nurse practitioners, hospitalists, physician 
assistants, respiratory therapists, others who perform tracheal 
intubations under attending physicians’ supervision):  
Exclusion Criteria 
 
None 
Number Of Subjects  
 
Total Number of Subjects: 240 faculty across approximately 10 
NICUs, Total Number of Sites: 10 sites 
Study Duration 
Each subject’s participation will last for 2 years 
The entire study is expected to last 2 years 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
This study have 3 phases.  
Pre-intervention phase: evaluation of tracheal intubation with or 
without video laryngoscopy use as a baseline 
Transition phase: From initiation of remote site leader training 
(‘train the trainer’ session) until the pre-defined site-level uptake 
(>70% VL use for trainee/frontline TIs per month). 
Post-intervention phase: We will continue to capture all TIs after 
VL use meets criteria >70%.   
Efficacy Evaluations 
Occurrence of adverse TIAEs 
Safety Evaluations 
The occurrence of adverse TIAEs, desaturation, and multiple 
attempts 
Statistical And Analytic 
Plan 
For primary and secondary endpoint (adverse TIAEs, severe 
desaturation rate), the event rates will be compared between pre-
intervention phase and post-intervention phase. We plan to censor 
the transition phase for the primary analysis.  
For secondary endpoint (duration till completion of faculty training 
and faculty performance during transition/post-intervention phase), 

 
 
 
 
 
 
 
 
 
 
ix
a summary statistics will be developed and will be compared against 
effect size (decrease in adverse TIAE rates) and VL use.  
DATA AND SAFETY 
MONITORING PLAN 
The plan for tracheal intubation data accuracy and safety is under 
NEAR4KIDS protocol CHOP IRB number 09-007253.  Regarding 
the neonatology faculty training data, data manager will be in 
charge for the accuracy, quality and safety of the data. Data will be 
kept in REDCap database with only limited access to PI, Data 
Coordinator and Data manager.  

 
x  
 
 
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES  
Study Phase 
Screening/
Training 
Follow 
up 
Visit Number 
1 
2 
Study Days 
 
 
Informed Consent 
X 
 
Review Inclusion/Exclusion 
Criteria 
X 
 
Demographics 
X 
X 
Training by site leader 
X 
 
Remote simulation for skill 
assessment 
 
 

 
  
 
 
 
1
 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 
Introduction 
Tracheal intubation (TI) is the most common life-saving intervention for resuscitation and 
stabilization of critically ill neonates in Neonatal Intensive Care Units (NICUs). More than 
400,000 neonates are admitted to NICUs in the US annually, and 10%-15% of these infants 
(>40,000) require TI to sustain life. TI procedures are high risk. Adverse TI associated 
events are frequent (20%) and severe desaturation during TI (>20% absolute decrease in 
oxygen saturation) occurs in >50%. Neonatal TIs have unique risks related to difficult 
airway anatomy (e.g., anterior larynx) and physiology (e.g. limited pulmonary oxygen 
reserve) requiring prompt procedural success. Provider technical skills, suboptimal TI 
approach such as underuse of neuromuscular blockade, and communication errors contribute 
to neonatal TI risks.  
Previous TI studies indicate that training level and multiple attempts are associated with 
adverse TI associated events and severe desaturation. Video laryngoscopy (VL) is now 
available in neonatal practice, but standard direct laryngoscopy technique for TI remains a 
core clinical skill. Newer VL technology allows trainees and frontline providers to perform 
standard traditional laryngoscopy while their supervisor can simultaneously view a real time 
video display of what the trainee/laryngoscopist is actually seeing. This technology enables 
expert “coaching” by a supervisor for the hazardous TI procedure. 
1.2 
Name and Description of Investigational Product or Intervention 
Novel video laryngoscope assisted real-time coaching intervention can reduce adverse TI 
associated events. All neonatology attendings, NPs, PAs and RTs will be trained for video 
laryngoscope real-time coaching education and 20% of them will be assessed by remote 
simulation.   
1.3 
Findings from Non-Clinical and Clinical Studies  
1.3.1 Clinical Studies in Adults 
Many adult studies on urgent endotracheal intubations in emergency departments and adult 
medical intensive care units have demonstrated the utility of video laryngoscopy over direct 
laryngoscopy to achieve higher first-attempt and ultimate success rates for tracheal 
intubation. (Reference 1-5)  Direct laryngoscopy requires that the laryngoscope operator 
align the oral, pharyngeal, and laryngeal axes to obtain a clear view of the glottis inlet. In 
contrast, manipulation of a video laryngoscopy does not require alignment of these 3 axes in 
order to achieve a view of the glottic inlet on a video screen due to a magnified and 
panoramic view projected from a light source and micro-video camera mounted on the end 
third of the laryngoscope blade. (Reference 6) 
A recently published prospective randomized control study in French ICUs showed video 
laryngoscopy use without appropriate training was not associated with higher first attempt 
success rate (Reference 7).  This study demonstrated that video laryngoscopy is a different 
technique. Therefore we plan to use video laryngoscopy as a traditional laryngoscopy device 

 
  
 
 
 
2
and as a method to provide necessary information to supervisors to coach standard tracheal 
intubation.  
1.3.2 Clinical Studies in Children 
A recent meta-analysis evaluating video laryngoscopy in operating suites revealed equivocal 
results. (Reference 8) A retrospective study analysis from a large pediatric ICU and ED 
patients showed the use of video laryngoscopy is associated with a decreased occurrence of 
adverse tracheal intubation associated events, especially in esophageal intubations. 
(Reference 9) 
Recent studies from neonatal ICUs showed substantial safety gaps in tracheal intubation 
success rates, adverse tracheal intubation associated events rate and multiple attempt rates. 
(Reference 9). A report from our collaborating sites showed the use of video laryngoscopy 
improved the success rate during trainee’s learning process. (Reference 10) 
1.4 
Relevant Literature and Data 
As described above, there are large body of evidence to support video laryngoscopy use in 
operating and non-operating environment.  A limited number of literature in pediatrics and 
neonatal fields demonstrated that the use of video laryngoscopy is helpful in improving 
procedural success. There is evidence that the use of video laryngoscopy is becoming more 
common across pediatric practice. (Reference 9)  
1.5 
Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46, 21 CFR Parts 50, 54, and 56.  
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  
2 
STUDY OBJECTIVES 
The purpose of the study is to determine the efficacy of video coaching training for 
neonatology attending providers on tracheal intubation procedural outcomes in neonatal 
ICUs.  
2.1 
Primary Objective (or Aim) 
The primary objective of this study is to determine the whether the video coaching skill 
training for neonatology attendings, NPs, PAs, and RTs reduces the occurrence of adverse 
tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 
years before and after intervention.  

 
  
 
 
 
3
2.2 
Secondary Objectives (or Aim) 
The secondary objectives are to: 
 Determine if video coaching training is feasible to all neonatology attending physicians, 
NPs, PAs and RTs using train the trainer approach with a remote simulation 
 Determine  the video coaching skill competency among neonatology attending 
physicians, NPs, PAs and RTs who completed the training using a remote simulation 
 
3 
INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
3.1.1 Screening Phase 
Our study intervention subjects are neonatology attending physicians, nurse practitioners, 
physician assistants and respiratory therapists. They will be identified by each site leader 
(also a neonatology attending physician) participating in this multicenter study. 
3.1.2 Study Treatment Phase (start of the study intervention) 
Pre-intervention phase: evaluation of tracheal intubation without video laryngoscopy 
coaching language use as a baseline. Each site tracheal intubation outcomes (adverse 
tracheal intubation associated events rate, first attempt success rate) will be documented.  
3.1.3 Transition Phase  
Transition phase: From initiation of remote site leader training (‘train the trainer’ session) 
between the overall PI and site leaders, until the pre-defined site-level uptake (>70% VL use 
for trainee/frontline TIs per month). The tracheal intubation data during this period will be 
censored for a primary analysis, and will be used for secondary analyses. 
3.1.4 Follow-up Phase 
Post-intervention phase: We will continue to capture all TIs after VL use meets criteria 
>70% for up to 2 years at each participating neonatal ICU. 
3.2 
Allocation to Treatment Groups and Blinding 
All neonatal attending providers,nurse practitioners, physician assistants and respiratory 
therapists will receive a video coaching training by a site leader if a written consent is 
obtained. There is no allocation of treatment groups.  
After their initial video coaching training, 20% of the neonatology attending physicians, 
nurse practitioners, physician assistants and respiratory therapists will be randomly chosen 
to participate in a follow up skill evaluation with a remote simulation. This 20% will be 
chosen by DCC to provide a random number for a given number of neonatology attendings, 
nurse practitioners, physician assistants and respiratory therapists who participated in the 
initial training. Each participated neonatologist, NP, PA and RT will be assigned a number 
based on the order of participation to the training. For example, if there are 20 
neonatologists participated in the initial training in one neonatal ICU, 4 of them will be 

 
  
 
 
 
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invited for remote simulation based on a 4 random numbers (between 1-20) provided by 
DCC for this site.  
3.3 
Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration per subject (neonatologist attendings, NPs, PAs and RTs) will be up to 
18 months, the longest. After their initial video coaching training, 20% of the attending 
physicians, NPs, PAs, and RTs will be randomly chosen to participate in a follow up skill 
evaluation with a remote simulation.  
The study duration per subject (nurse practitioners, hospitalists, physician assistants, 
respiratory therapists, others who perform tracheal intubations under attending physicians’ 
supervision) will be up to 24 months, the longest. They may be approached for study 
consents before their NICU rotation.  
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at approximately 10 investigative sites in the United States and 
Canada. 
Recruitment will stop when a total of 2 years of study participation at the site has been 
completed.  
We plan to recruit all neonatology attending physicians, nurse practitioners, physician 
assistants and respiratory therapists practicing in participating sites. We anticipate this will 
be approximately 240 providers.  
We plan to recruit all trainees and frontline providers who are qualified to perform tracheal 
intubation under attendings supervision. We anticipate this will be approximately 1800 
providers.  
3.4 
Study Population 
3.4.1 Inclusion Criteria 
Two types of study population exist in this protocol.  
1) VL coach: Neonatology attending physician position at each neonatal ICU, or Senior 
trainees who are anticipated to graduate within next 6 months to become neonatology 
attending physicians, nurse practitioners with over 5 years of clinical experience, 
physician assistants,  and respiratory therapists with over 5 years of clinical neonatology 
experience.  
2) VL coach receivers: Trainees (medical students, residents, fellows except those 
graduating within next 6 months) and frontline providers (nurse practitioners, 
hospitalists, physician assistants, respiratory therapists, others who perform tracheal 
intubations under attending physicians’ supervision):  

 
  
 
 
 
5
3.4.2 Exclusion Criteria 
 
None 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
4 
STUDY PROCEDURES 
4.1 
Screening/Initial training Visit 
 Informed Consent (neonatology attending providers, NPs, PAs and RTs) 
 A written informed consent will be obtained by all participating neonatology 
attending providers, nurse practitioners, physician assistants and respiratory 
therapists at each site.  
 A verbal informed consent will be obtained by all participating trainees and 
frontline providers.  
 Demographic information (neonatology attending providers, NPs, PAs, RTs, trainees 
and frontline providers) 
 After informed consent is obtained, demographics information outlined in section 
5.1.1. will be obtained.  
 Initial video laryngoscopy coaching training to neonatology attending providers by a 
site leader 
Each neonatology attending provider, NP, PA and RT will receive a video 
laryngoscopy coaching training using a C-MAC video laryngoscope and an 
intubation training manikin available at each site by a site leader. During the 
training, site leader will act as a trainee confederate, and each neonatology 
attending provider, NP, PA, and RT will be trained to coach a trainee utilizing 
video images from C-MAC video laryngoscope and a cognitive aid with 
standardized language in a laminated card. This training part typically takes 
approximately 15-30 minutes including consenting process.  
Each site leader will be trained by PI or PI’s designee using remote simulation. In 
this remote simulation, each site leader will coach an actor at CHOP using a 
profile video image and C-MAC video laryngoscopy image through CHOP 
approved video conferencing software. A standardized language will be taught to 
each site leader with a cognitive aid (laminated card).  
 

 
  
 
 
 
6
4.2 
Follow Up Phase 
4.2.1 Visit 1 
Selected neonatology attendings, NPs, PAs and RTs will participate in a remote simulation 
session.  
A follow up of simple demographic information will be collected. 
Follow up skill evaluation utilizes a remote simulation. Selected neonatology attendings, 
NPs, PAs and RTs will remotely coach an actor at the Children’s Hospital of Philadelphia 
using the C-MAC video laryngoscope images and a standardized language. (A repeat of 
initial coaching training). Their coaching skills regarding how they used video laryngoscope 
images and coaching languages appropriately will be assessed by analyzing audio-recorded 
communication between an actor at the Children’s Hospital of Philadelphia and site 
neonatology attendings,NPs, PAs, and RTs. 
Trainees will be coached as usual during their supervised intubation events and the results of 
these events as described under CHOP IRB# 09-007253 will be used as part of the analysis. 
4.3 
Subject Completion/Withdrawal 
Subjects (neonatology attending providers, NPs, PAs, RTs, trainees and frontline providers) 
may withdraw from the study at any time without prejudice to their practice.  However, 
overall tracheal intubation safety practice data (rate of adverse tracheal intubation associated 
events) at each site will be collected throughout regardless of the provider’s status under 
CHOP IRB# 09-007253. Participating sites may also be discontinued from the study at the 
discretion of the Principal Investigator for lack of adherence of site leader to educate 
neonatologists.  
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 
Screening and Monitoring Evaluations and Measurements 
5.1.1 Demographic Data Collection 
Brief demographic data of each neonatology attending, NP, PA, and RT participant (subject) 
will be obtained. These data points are listed below: 
 Age 
 Gender  
 Years of experience as neonatology attending 
 Years of experience in Neonatology as a Nurse Practitioner 
 Years of experience in Neonatology as a Respiratory Therapist 
 Years of experience in Neonatology as a PA 
 Year of neonatology fellowship completion 
 Year of completed NP training 
 Year of completed RT training 
 Year of completed PA training 
 Experience in video laryngoscopy use 

 
  
 
 
 
7
 Months of experience in video laryngoscopy use 
Brief demographic data of each neonatology trainees and frontline providers will be 
obtained. These data points are listed below. 
 Age 
 Gender 
 Training level 
 Training experience (type and length of residency training, type and length of 
fellowship training) 
 Training experience before joining post-graduate education in the United States 
 Experience in laryngoscopy use (number of previous intubation in patients) 
 Confidence in laryngoscopy use (Likert scale) 
5.1.2 Other Evaluations, Measures 
A remote simulation session will be held to assess neonatology attending,NP, PA, and RT 
(subject)’s coaching skills. This session will be conducted between the Children’s Hospital 
of Philadelphia and each participating site for 20% of randomly selected neonatologists. The 
session will be video and audio recorded. The session will be transcribed without any 
identifiable information, and the original recording video and audio information will be 
destroyed once the audio is transcribed and annotation is made for each step of tracheal 
intubation. This transcribed information will be assessed for the accuracy of the coaching 
language during video laryngoscopy tracheal intubation by trainees. Each subject’s score 
will not be shared with their local site leader, and only summary statistics (mean and 
standard deviation or median and interquartile range) will be shared.  
5.2 
Efficacy Evaluations 
5.2.1 Diagnostic Tests, Scales, Measures, etc. 
The endpoint data will be obtained from the study database (NEAR4NEOS) under 
“Observation of Multi-center Quality Improvement Project: Improving Safety and Quality 
of Tracheal Intubation Practice in Pediatric ICUs” (At CHOP, the IRB study number is#09-
007253).. The NEAR4NEOS only contains limited dataset with only not readily identifiable 
data. For each tracheal intubation, involved neonatology attending and trainee or frontline 
providers will be recorded with subject ID by site team, and therefore the study team will 
not be able to identify provider subjects. All participating sites have CHOP IRB study #7253 
and they will have outcome data available.  
Study provider participation in tracheal intubation events will be captured by utilizing the 
existing NEAR4NEOS REDCap data entry system by adding two data points: provider ID 
for coach and trainee/frontline providers who received coaching. Specifically provider ID 
for coach and trainee or frontline providers who received coaching will be recorded for each 
tracheal intubation encounter. No readily identifiable data related to the patients will be 
extracted. This limited dataset including provider ID for coach and trainees who received 
coaching will be extracted by Data Coordinating Center for NEAR4NEOS (the current study 
coordinator and study PI serves as the core members of Data Coordinating Center for 
NEAR4NEOS). The dataset will be password protected. Also the study coordinator and PI 

 
  
 
 
 
8
will obtain study ID demographics dataset from each participating center (no PHI will be 
contained in this dataset), and merge these dataset by linking subject IDs. The Merged 
dataset will not contain any PHIs of the subjects. 
5.3 
Safety Evaluation 
Since the study intervention is an educational intervention to faculty provider, and provider 
will continue to perform current practice (direct laryngoscopy with the same blades, as 
opposed to learning new technique using video laryngoscopy), there is no considerable 
potential harm associated with intervention.  
The primary study endpoint is the procedural safety outcome, and we will continue to 
monitor this outcome throughout the educational intervention and post-intervention phase.  
Each site will receive aggregate data feedback periodically for benchmark and quality 
improvement purposes.  
6 
STATISTICAL CONSIDERATIONS 
6.1 
Primary Endpoint 
The primary endpoint will be the change in the occurrence of adverse tracheal intubation 
associated events among all primary tracheal intubations in neonatal ICUs between pre-
intervention phase and post-intervention phase.  
Secondary endpoints will include the following: 
 The change in the occurrence of severe oxygen desaturation (absolute oxygen saturation 
drop >20% from baseline) across 10 academic NICUs 
 The duration to complete neonatology faculty training from the initial train the trainer 
session for site leaders.  
 The coaching skills of randomly selected faculty after initial training at each site 
 
6.2 
Statistical Methods 
6.2.1 Baseline Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for normally distributed continuous variables 
such as age and median and interquartile range for non-normally distributed continuous 
variables, and percentages for categorical variables such as gender). 
6.2.2 Efficacy Analysis 
The primary efficacy endpoint will be the change in the occurrence of adverse tracheal 
intubation associated events among all primary tracheal intubations in neonatal ICUs 
between pre-intervention phase and post-intervention phase.  

 
  
 
 
 
9
Secondary endpoints will include the change in the occurrence of severe desaturation 
(absolute oxygen saturation drop >20% from baseline) between pre-intervention phase and 
post-intervention phase.  
6.2.3 Safety Analysis 
All primary tracheal intubation data at each site will be included in the safety analysis, 
regardless of their neonatology attending provider training completion. The frequencies of 
AEs by type, body system, severity and relationship to study drug will be summarized. 
SAEs (if any) will be described in detail. 
AE incidence will be summarized along with the corresponding exact binomial 95% two-
sided confidence intervals. 
6.3 
Sample Size and Power 
For the primary outcome of the occurrence of TIAEs, we plan to obtain a data from ongoing 
observational study database (NEAR4NEOS) for a total sample size of 2,900 tracheal 
intubations:145 tracheal intubations during pre-intervention and 145 tracheal intubations 
during post-intervention phase per site from 10 sites over 2 years (a total of 1450 tracheal 
intubations before the intervention and 1450 intubations after the intervention).We anticipate 
a decrease of adverse TIAEs from 20% to 16 % (absolute risk reduction of 4%, relative risk 
reduction of 20%). Note this estimate is adjusted to account for site-level clustering. Also 
the number of tracheal intubations will be variant across the sites. Since this study is an 
educational intervention and pre-post design, we will include all tracheal intubation data 
during the 2 year study period. 
6.4 
Interim Analysis. 
No stopping rule is applied. Each site performance in tracheal intubation safety and video 
laryngoscopy use will be reported in aggregate as benchmark data as a part of quality 
improvement activity during the study period.  
7 
SAFETY MANAGEMENT 
7.1 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
7.2 
Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review. 

 
  
 
 
 
10
8 
STUDY ADMINISTRATION 
8.1 
Treatment Assignment Methods 
8.1.1 Randomization 
20% of initially trained neonatology attendings, NPs, PAs and RTs (subjects) will be 
remotely assessed for their coaching skills. A random number will be generated through 
www.random.org or Stata (STATA Corp, College Station, TX) at the The Children's 
Hospital of Philadelphia using a total number of neonatologists at each relying site. The 
number will be randomly selected for 20% (i.e., if there were 20 neonatologists, NPs PAs, 
and RTs for a given site, 4 numbers from 1-20 will be randomly selected). Each site leader 
will identify the neonatologists, NPs, PAs, and RTs who participated in the initial training in 
the order (4th, 16th, 9th, and 2nd, for example) using their initial enrollment log. 
 
 
8.2 
Data Collection and Management 
1. Confidentiality.  
 Each site will generate a master list of neonatology attending providers, NPs, PAs,  
and RTs (subjects) being trained using password-protected Excel files. This master 
list will contain only their name and date of training, and the training order at each 
site which will be used as subject ID number.  The master list should be kept on a 
separate computer or in a locked file cabinet. This local master list will not be shared 
with other sites to ensure confidentiality.  
 Scores of each site neonatologists, NPs, PAs, and RTs who participated in follow up 
assessment remote simulation will be kept confidential at The Children's Hospital of 
Philadelphia and only a summary statistics will be shared with each site leader.  
 Relying sites will enter data in the password protected CHOP REDCap database. 
2. Security.  A copy of this password-protected Excel file will be kept under hospital 
protected server at each site. 
3. Anonymization, de-identification or destruction.  This master list will be destroyed 
upon completion of data collection.  
4. The clinical procedural outcome data (adverse TIAE rate) will be obtained from on-
going QI research database: NEAR4NEOS (At CHOP, the IRB study number is#09-
007253). A limited dataset will be downloaded for the primary and secondary 
analyses. Except the date of procedure, there is no protected health information of 
patients is included in this database.  
5. This plan is consistent with CHOP Policy A-3-6: Acceptable Use of Technology 
Resources 

 
  
 
 
 
11
8.3 
Confidentiality 
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 
any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI 
limited to dates).  
8.4 
Regulatory and Ethical Considerations 
8.4.1 Risk Assessment 
Risks for both neonatology attending providers, NPs, PAs, RTs and trainees/frontline 
providers are not greater than minimal risk, limited to a potential breach of confidentiality. 
 The study design and execution will minimize the risks of harm as described in section 7.2. 
In addition, an independent Data Safety and Monitoring Board (DSMB) will be developed with 3-6 
experts in neonatology, in human subject protection and regulatory oversight, statistics, and patient 
safety.  The members of DSMB must be independent from study and educational activities involved 
in this study. The DSMB is required to discuss the study (either face to face close meeting or private 
conference call without investigators) at least twice a year and review the report independently sent 
from biostatistician to monitor the safety data. The DSMB may request additional reports from PI for 
overall activity progress at participating sites. 
The Data Safety Monitoring Board (DSMB) will independently review the data related TI associated 
event rates (primary outcome) and secondary outcomes: proportion of severe desaturation, severe 
adverse TI associated events, and proportion of TIs required > 2 attempts, to evaluate for negative 
effects on these outcomes at least every 6 months. If the intervention has statistically significant 
negative effect on primary or secondary outcomes for two consecutive analyses, DSMB may inform 
each site to temporarily hold the educational interventions and request to review the process. 
 
8.4.2 Potential Benefits of Trial Participation 
The potential direct benefit for the faculty study participation is to receive a standardized 
education to coach trainee or frontline providers’ tracheal intubation procedure using a video 
laryngoscopy.  
The indirect benefits will be the participation in scientific evaluation of the use of coaching 
language in neonatal tracheal intubation using video laryngoscope. Since this video 
laryngoscope use is becoming standard of care in many institutions, the evaluation of the 
impact of standard coaching language will be of merit to the neonatal community. 
For the trainees/frontline providers, their direct benefit will be that they may receive clear 
coaching during tracheal intubation procedure.  
The indirect benefits will be similar: the participation in scientific evaluation of the use of 
coaching language in neonatal tracheal intubation using video laryngoscope. 
8.4.3 Risk-Benefit Assessment 
The risk of this study participation is limited to breach in confidentiality. Each faculty’s 
assessment will be strictly kept confidential through follow up assessment with remote 

 
  
 
 
 
12
simulation. No readily identifiable data related to the patients will be extracted.. Therefore 
this risk is minimal. 
The potential benefit for the faculty study participation is to receive a standardized education 
to coach trainee or frontline providers’ tracheal intubation procedure using a video 
laryngoscopy.  
Given the risk is minimal with a potential benefit, the study participation is justified. 
8.5 
Recruitment Strategy 
Each site leader will communicate with their colleague neonatology attending providers, 
NPs, PAs, and RTs through electronic mails, their local conference, or meetings.  
Each site data coordinator will communicate with trainees/frontline providers through 
electronic mails, their local conference, or meetings. 
8.6 
Informed Consent/Assent and HIPAA Authorization 
A written informed consent will be obtained from each participating neonatology attending 
providers,NPs, PAs, and RTs. No readily identifiable data related to the patients will be 
extracted.. HIPAA does not apply to this study as no health information about the subjects 
(attendings, NPs, PAs, RTs and trainees) will be collected. 
A verbal consent will be requested for trainee/frontline providers.  
A verbal consent is requested for trainees and frontline providers because  
(1) The study procedures are not greater than minimal risk 
(2) The procedures do not require written consent outside of the research 
context.  
8.6.1 Waiver of Consent 
Not applicable 
8.6.2 Waiver of Assent 
Not applicable 
8.6.3 Waiver of HIPAA Authorization 
Request for a waiver of HIPAA authorization for the transfer of a limited data set 
from IRB study #7253 to the current protocol.  
8.7 
Payment to Subjects/Families 
8.7.1 Gifts 
Neonatology attending providers, NPs, PAs and RTs who are invited to participate in a 
follow up skill assessment through remote simulation will be given 20 dollar gift card as a 
token of appreciation.  

 
  
 
 
 
13
9 
PUBLICATION 
The CHOP investigator (Principal Investigator) will have access to the complete data (both 
neonatology attendings, NPs, PAs, RTs and trainees/frontline providers).  
We will analyze the data based on our primary and secondary endpoints, and will present the 
data in peer review publications regardless of the result. 
10 REFERENCES 
1. De Jong A, Molinari N, Conseil M, et al. Video laryngoscopy versus direct 
laryngoscopy for orotracheal intubation in the intensive care unit: a systematic 
review and meta-analysis. Intensive Care Med 2014;40(5):629-639. 
2. Jones BM, Agrawal A, Schulte TE. Assessing the efficacy of video versus direct 
laryngoscopy through retrospective comparison of 436 emergency intubation cases. J 
Anesth 2013;27(6):927-930. 
3. Sakles JC, Mosier J, Chiu S, et al. A comparison of the C-MAC video laryngoscope 
to the Macintosh direct laryngoscope for intubation in the emergency department. 
Ann Emerg Med 2012;60(6):739-748. 
4. Su YC, Chen CC, Lee YK, et al. Comparison of video laryngoscopes with direct 
laryngoscopy for tracheal intubation: a meta-analysis of randomised trials. Eur J 
Anaesthesiol 2011;28(11):788-795. 
5. Brown CA, 3rd, Bair AE, Pallin DJ, et al. Techniques, success, and adverse events of 
emergency department adult intubations. Ann Emerg Med 2015;65(4):363-370 e361. 
6. Kaplan MB, Hagberg CA, Ward DS, et al. Comparison of direct and video-assisted 
views of the larynx during routine intubation. J Clin Anesth 2006;18(5):357-362. 
7. Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, 
Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain  
T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care 
and Sepsis (CRICS) Group.. Video Laryngoscopy vs Direct Laryngoscopy on 
Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized 
Clinical Trial. JAMA. 2017 Jan 24. 
8. Sun Y, Lu Y, Huang Y, et al. Pediatric video laryngoscope versus direct 
laryngoscope: a meta-analysis of randomized controlled trials. Paediatr Anaesth 
2014;24(10):1056-1065. 
9. Grunwell JR, Kamat P, Walson K, Krishna A, Gradidge E, Nadkarni V, Nishisaki A; 
for the National Emergency Airway Registry for Children (NEAR4KIDS) and 
Pediatric Acute Lung Injury and Sepsis (PALISI) Network: Trends and outcomes of 
video laryngoscope use across pediatric intensive care units. Critical Care Medicine 
43(12 Suppl), December 2015  
10.  Foglia EE, Ades A, Napolitano N, Leffelman J, Nadkarni V, Nishisaki A. Factors 
Associated with Adverse Events during Tracheal Intubation in the NICU. 
Neonatology. 2015;108(1):23-9.  
11. Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. 
Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized 
Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156.  
 
 

 
  
 
 
 
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APPENDIX I 
COGNITIVE AID 
SITUATION 
COACHING LANGUAGE 
Start laryngoscopy attempt 
 
“Are you ready?” 
‘Start” 
Laryngoscope too deep 
 
“Pull back slowly” 
Laryngoscope too shallow 
“Advance the blade” 
Laryngoscope too left (tongue 
visible on right) 
“Move blade to YOUR RIGHT” 
Rocking motion 
“Don’t rock” “ Pull up and away 
toward the direction of the 
handle” 
Floppy epiglottis needs to be lifted 
up 
“Lift up the epiglottis” 
Seeing glottic opening and ETT to 
be inserted 
“Do you see the cords?” 
“Insert ETT” 
Check ETT placement with ETCO2 
Simple command is sufficient 
“Check End-tidal CO2” 
Spending long time with 
desaturation 
 “Come Out” 
Bag mask ventilation needs to be 
started for desaturation 
“bag him/her up” 
 
 
 

 
  
 
 
 
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APPENDIX II 
C-MAC Video Laryngoscope coaching training  
 
Neonatology Attending, NP, PA and RT Training 
Checklist 
 
Center: _____________________ 
 
Date:  ______________________                Subject ID: ________________ 
 
Trainer: _____________________ 
 
 
 State rationale to use video laryngoscope as a primary coaching device  
 
 C-MAC orientation (how to turn on the switch, how to record and replay, 
now to change the brightness) 
 
 Master Coaching language (Hands-on simulation with an actor) 
 
 Become aware of the follow up evaluation using remote simulation (20% of 
attendings)