Tracheal Intubation Coaching in NICUs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.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. The primary objective of this study is to determine whether the video coaching skill training for neonatology attendings reduces the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years before and after intervention. The secondary objectives are to 1) determine if video coaching training is feasible to all neonatology attending physicians using train the trainer approach with a remote simulation and 2) determine if the video coaching skill competency among neonatology attending physicians who completed the training using a remote simulation

Official Title
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Improving Safety and Quality of Tracheal Intubations in Neonatal ICUs

Conditions
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Failed or Difficult Intubation, Sequela, Intubation;Difficult, Intubation Complication

Intervention / Treatment
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* Device: VL Coaching training using C-MAC video laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Attendings<br>Study intervention is a VL coaching training for site neonatology attendings. Each site leader/key educator will be trained remotely by expert co-investigators. Site leaders and key educators will train their attendings. The quality of VL coaching skills will be verified by randomly auditing 20% of attending providers at each site for their skill assessment by remote simulation during the transition/post-intervention phase. | Device: VL Coaching training using C-MAC video laryngoscope<br>* Each neonatology attending providers 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 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 the Children's Hospital of Philadelphia (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).<br>|
| No Intervention: Trainees<br>Trainees will be coached as usual by attendings during their supervised intubation events | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years | Reduction in the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years after neonatology attendings receive video coaching skill training. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching | Intubations with VL coaching vs. no VL coaching (incl: DL&VL) can reduce severe oxygen desaturation: Oxygen desaturation defined as highest -lowest SpO2 during the intubation is >20% (absolute value). Intervention timing was randomized based on the site size. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Video Laryngoscope, Coaching/training