Tracheal Intubation Coaching in NICUs

Intubation Complication Clinical Trial

Official title:

Improving Safety and Quality of Tracheal Intubations in Neonatal ICUs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194503
• Other study ID #: 16-013606
• Secondary ID: 1R21HD089151-01A
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1512
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

Inclusion Criteria:

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.

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) Exclusion Criteria: None

Related Conditions & MeSH terms

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

Intervention

Device:
• VL Coaching training using C-MAC video laryngoscope
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).

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec
Singapore	KK Women's and Children's Hospital	Singapore
United States	University of Colorado Hospital	Aurora	Colorado
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of California San Diego Jacobs Medical Center	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Yale New Haven Children's Hospital	New Haven	Connecticut
United States	WakeMed	Raleigh	North Carolina
United States	Seattle Children's Hospital	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington

Countries where clinical trial is conducted

United States,  Canada,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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