Manikin To Patient Intubation: Does It Translate?
Phase: NA
Conditions: Intubation; Difficult or Failed
Sponsor: University of Arkansas

TITLE:  MANIKIN TO PATIENT INTUBATION: DOES IT TRANSLATE?” 
PI:         R. Whit Hall, M.D. 
 
Version #3 
Date: September 19, 2017 
 
pg. 1 
 
 
 
Study Title: 
 
 
“Manikin To Patient Intubation: Does It Translate?” 
 
 
Principal Investigator: 
R. Whit Hall, M.D. 
 
 
 
 
University of Arkansas for Medical Sciences 
 
 
 
 
4301 W. Markham Street, Slot #512-5B 
 
 
 
 
Little Rock, Arkansas  72205 
 
 
 
 
Telephone:  501.603.1255 
 
 
 
 
Email: HallRichardW@uams.edu 
 
 
Study Location: 
 
University of Arkansas for Medical Sciences 
 
 
 
 
4301 W. Markham Street 
 
 
 
 
Little Rock, Arkansas  72205 
 
 
 
Version No.:  
 
Protocol Version #3 
 
 
Date:  
 
 
September 19, 2017 
 
 
NCT number:  
 
NCT03046966 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

TITLE:  MANIKIN TO PATIENT INTUBATION: DOES IT TRANSLATE?” 
PI:         R. Whit Hall, M.D. 
 
Version #3 
Date: September 19, 2017 
 
pg. 2 
 
 
 
 
 
Abstract 
 
Tracheal intubation of infants and children is a critical lifesaving skill, and its importance is 
recognized by the Accreditation Council on Graduate Medical Education (ACGME), Residency 
Review Committee (RRC), the Neonatal Resuscitation Program (NRP) and Pediatric Advanced 
Life Support (PALS) programs. Despite its importance, current training is lacking in teaching this 
critical procedural skill as demonstrated by the inability of up to 1/3 of upper level Pediatric 
residents to be able to successfully intubate Very Low Birth Weight (VLBW, <1500 grams) 
neonates. New technology, which has now been adapted to the existing telemedicine network in 
Arkansas, offers an exciting opportunity to improve the ability of pediatric trainees to accomplish 
this critical task. We will utilize a deliberate practice approach with immediate feedback during 
neonatology rotations using the Storz video laryngoscope to teach this critical skill to Pediatric 
and Med-Peds residents (n=95 residents total). Previous work demonstrated improvement in 
skills with a manikin, but it is unknown if these skills will translate to live intubations. The 
residents will receive training during alternating months, and will be recorded during live 
intubations. We will assess how intubation skills using a manikin translates to live patients. We 
anticipate this training will dramatically improve intubation skills and resident confidence as 
evidenced by intubation accuracy. 
 
 
Project Narrative 
 
Background and Significance 
Tracheal intubation is one of the most important interventions in the stabilization of critically ill or 
injured children.  Advanced airway skills training is one of the major pillars of the ACGME 
pediatric program requirements for resident and fellowship education (Accreditation Council for 
Graduate Medical Education, 2007).  The pediatric airway presents unique anatomic challenges 
depending on the patient age, size and underlying condition.  These challenges, coupled with 
low frequency of pediatric trainee exposure to advanced airway management, make tracheal 
intubation procedural competency difficult to achieve.  As a result, tracheal intubation in infants 
and children is associated with high levels of operator stress as well as patient morbidity and 
mortality.1-3 
The ability to manage the pediatric airway, which includes anticipating potential difficulties and 
choosing an appropriate approach, remains one of the most vital skills to develop when caring 
for critically ill children.  Provider training level has been found to correlate with patient outcome 
during advanced airway management in selected environments including the operating room, 
delivery room and Neonatal Intensive Care Unit (NICU).3-5  Pediatric trauma patients intubated 
by less experienced emergency medical personnel in the field have increased morbidity and 
mortality when compared to similar patients intubated by pediatric-trained hospital personnel.6  
A limited number of studies from neonatal resuscitation demonstrated that resident trainee 
success rates are moderate at best, with 1/3 of upper level pediatric residents unable to intubate 
a very low birth weight (<1500 grams) neonate.5,7,8 The RRC agreed that neonatal intubation is 
a critical skill, but respondents to a survey sent to Residency Program Directors determined that 
“many residents do not develop competence in that area” and that a “more robust and 
standardized method is needed for teaching procedural skills and for documenting 

TITLE:  MANIKIN TO PATIENT INTUBATION: DOES IT TRANSLATE?” 
PI:         R. Whit Hall, M.D. 
 
Version #3 
Date: September 19, 2017 
 
pg. 3 
 
competence”.9 A survey of pediatric emergency room directors found that the number of 
intubations necessary to maintain skill in this area was inadequate.10 Even more concerning is 
that procedural skills such as intubation deteriorate rapidly over time (within the first year).11 
 
Our findings suggest that the training of pediatric residents is not sufficient prior to “live” tracheal 
intubations in the critical care setting.  The current one to two days of airway management 
training as a part of resuscitation training (such as PALS or NRP) is not sufficient to provide safe 
intubation skills.  A new approach to the instruction of tracheal intubation is needed for pediatric 
trainees, to decrease adverse events and to improve patient safety.12  One approach would be 
to develop and implement tracheal intubation training using concepts of deliberate practice 
modeled after Ericsson. The concepts include focused training on a specific task, immediate 
feedback, time for problem solving and evaluation, and opportunities for repeated 
performance.13,14  All pediatric residents will be required to meet a pre-set training goal 
(intubating a manikin consistently within 15 seconds, half the time allowed by NRP) in a 
simulation setting with intense, repeated training with feedback.  This proposal is an attempt to 
develop such a training model.    
 
Video laryngoscopy offers a potential solution to the problem of intubation training, because it 
allows the educator to actually “see” what the trainee is seeing with the laryngoscope. Although 
this mode of intubation has been used for some time with adult laryngoscopy, the technology 
has only recently been adapted for neonatal and pediatric use. One recent study found 
satisfaction with the proposed equipment, but patients were not randomized and its use in 
training has not been studied.15 The GlideScope, another brand of video laryngoscopy, has 
been used in children, providing better views, but intubation takes longer using this 
technology,16,17 and it does not adapt well for use in neonates and infants because of blade size. 
Interestingly, Skype has been used with this technology, but Skype offers limited resolution and 
is not HIPAA compliant.18 We have been able to demonstrate that this equipment significantly 
decreases intubation times in manikins. Now we must determine if this improvement translates 
into improved intubation skill in live patients.  
 
 
Hypothesis and/or Specific Aims or Objectives 
 
Specific Aim 1. Assess the impact of this educational manikin intervention on live patients. 
 
We hypothesize learners in the Intervention Group vs. the Control Group will have enhanced 
success in intubation as determined by the number of attempts and time required for intubation 
of live patients. 
 
Specific Aim 2. Assess the satisfaction of this educational intervention and equipment. 
 
We hypothesize pediatric residents will have increased satisfaction scores and confidence for 
intubating live patients in the Intervention Group vs. the Control Group. 
 
Specific Aim 3. Assess the association of confidence in intubation with actual success in 
intubation. 
 
We hypothesize increased confidence will be associated with increased intubation success. 
  
Target Audience 

TITLE:  MANIKIN TO PATIENT INTUBATION: DOES IT TRANSLATE?” 
PI:         R. Whit Hall, M.D. 
 
Version #3 
Date: September 19, 2017 
 
pg. 4 
 
 
The target audience will be Pediatric and Med-Peds residents. Total n = 95 potential 
participants 
 
Methods 
 
This research study will include 95 resident physicians. We anticipate 80 residents will enroll, 
similar to our previous study in which 82 residents participated. Residents will be randomized to 
the Intervention Group or the Control Group. This study will be explained to potential 
participants as they begin their assigned rotation to the Neonatal Intensive Care Unit (NICU). 
The explanation of the study and the Information Sheet will be introduced during the first five (5) 
days of this rotation. Residents will be allowed to ask any questions they feel necessary and 
take as much time as needed in order to make a fully informed voluntary consent. It will be 
explained that their participation in this study is completely voluntary and a decision to not 
participate will have no impact on their training or standing in the residency program. 
Randomization will occur by the month the resident is assigned to the NICU. 
 
All participants will: 
 
• 
Receive NRP training and certification offered at the beginning of their residency 
• 
Complete a Baseline Survey 
• 
Complete a Baseline Cognitive and Simulation Assessment 
• 
Have a Stabilization Room video recording as part of the quality improvement process 
for neonatal resuscitation 
• 
Complete a Cognitive and Simulation Assessment at the end of the month 
• 
Complete an End of Rotation Survey 
 
Residents who are randomized to the Intervention Group will, in addition: 
 
• 
Observe a 7 minute NRP video 
• 
Complete a hands-on intubation simulation with Dr. Hall instructing: 
o Using state of the art technology, a Storz C-MAC video laryngoscope 
o Identifying anatomical landmarks 
o Practice on the manikin until intubation occurs within 15 seconds 
 
During the monthly rotation of each resident, ongoing data will be collected on the residents’ 
ability to successfully intubate on the first attempt, the total number of attempts to intubate, and 
the total number of successful attempts at intubating a neonate within 30 seconds, the time limit 
set by NRP. All live intubations performed in the Stabilization Rooms will be recorded and 
reviewed by designated members of the NICU Safety Committee. The recorded videos of study 
participants will also be reviewed by Dr. Whit Hall and Jimmie Birdsong, R.N. The information 
obtained from the video recordings will be kept in a safe, secure file that is password protected. 
At the end of the monthly rotation each resident, including those in the Control Group, will be 
offered the opportunity to complete the Hands-on Intubation training simulation with Dr. Hall. 
 
Angel Eye Cameras and control modules will be placed on the patient beds in the NICU 
Resuscitation Rooms which will be used for recording and monitoring infant intubation 
procedures. The cameras will be placed on the bed above the infant and staff while the control 
panel will be on a nearby wall to allow for easy starting and stopping of recording and 
monitoring of recording during the procedure. The control panel will have access to start/stop 

TITLE:  MANIKIN TO PATIENT INTUBATION: DOES IT TRANSLATE?” 
PI:         R. Whit Hall, M.D. 
 
Version #3 
Date: September 19, 2017 
 
pg. 5 
 
recording as well as status and duration of recording. Recording will default to three (3) hour 
durations and can be extended from the control panel. All recordings will be managed by a 
video recording server and stored on network accessible server storage space. All videos will be 
labeled by date, time and bed space at which the recording took place. Staff can then log into 
the server and review videos to ensure proper intubation procedures have been followed and to 
improve training methods. 
 
Below is a technical workflow diagram: 
 
 
1. User accesses control panel to select camera at bed space. Control panel sends signal 
    to recording server to start recording on requested camera. 
2. Recording server requests video from camera. 
3. Camera starts sending video and audio data to recording server. 
4. Recording server stores video and audio data on video storage server. 
5. Staff can then access recorded data directly from the video storage server. 
 
Study Population 
 
Inclusion Criteria 
 
 
Male and female residents from 18-89 years of age who have been assigned to 
 
the NICU for a monthly rotation are eligible to participate. At the beginning of all 
 
NICU rotations, all pediatric residents will be invited to participate in this 
 
research. 
 
Exclusion Criteria 
 
 
Any pediatric resident who does not wish to participate 
 
 

TITLE:  MANIKIN TO PATIENT INTUBATION: DOES IT TRANSLATE?” 
PI:         R. Whit Hall, M.D. 
 
Version #3 
Date: September 19, 2017 
 
pg. 6 
 
 
 
 
Risks and Benefits 
 
The only potential risk to study participants is the potential for loss of confidentiality. Measures 
to protect the confidentiality of study participants will be implemented as described in the Data 
Handling and Recordkeeping section below. 
There will likely be direct benefits to the study participants to include enhanced instruction in 
neonatal intubation which would result in enhanced procedural skills for pediatric residents. 
Further, knowledge gained from the study could potentially benefit residents and community 
providers who are required to intubate, and their patients, in the future. 
 
Data Handling and Recordkeeping 
 
The Principal Investigator will carefully monitor study procedures to protect the safety of 
research subjects, the quality of the data and the integrity of the study. A unique identifying code 
or number will be assigned to the participant’s documents. In this way the data will remain 
anonymous. Only R. Whit Hall, MD and Jimmie Birdsong, RN will have access to study data and 
this data will be kept in a locked file in the principal investigator’s office. Jimmie Birdsong, RN 
will routinely transcribe the data collected to an electronic file using the unique identifying code 
or number for each participant. The electronic file will be placed on a password protected file 
located on the UAMS Server. All recordings will be managed by a video recording server and 
stored on network accessible server storage space.  
 
Evaluation Plan 
Using data from our previous intubation study using a manikin, we estimate a sample size for 
this study is 27 residents in each group. We recruited more than that for the manikin study, and 
for that study residents were required to come back for a post test. Thus, we anticipate no major 
difficulties in recruitment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

TITLE:  MANIKIN TO PATIENT INTUBATION: DOES IT TRANSLATE?” 
PI:         R. Whit Hall, M.D. 
 
Version #3 
Date: September 19, 2017 
 
pg. 7 
 
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