Tracheal Intubation Coaching in NICUs

NCT03194503 | Completed Results DMC FDA Device

• 2 other identifiers: 16-0136061R21HD089151-01A1
• Study Type: interventional
• Target: 1,512
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

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

Keywords

Intubation; Video Laryngoscope; Coaching/training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching

  18 months

Study Arms (2)

Attendings

ACTIVE COMPARATOR

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

Trainees

NO INTERVENTION

Trainees will be coached as usual by attendings during their supervised intubation events

Interventions

VL Coaching training using C-MAC video laryngoscope DEVICE

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).

Attendings

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Washington: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (10)

University of California San Diego Jacobs Medical Center

La Jolla, California, 92037, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Yale New Haven Children's Hospital

New Haven, Connecticut, 06510, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

CHU Sainte-Justine

Montreal, Quebec, QC H3T 1C5, Canada

Location

KK Women's and Children's Hospital

Singapore, 168753, Singapore

Location

Results Point of Contact

• Title: Dr. Akira Nishisaki
• Organization: The Children's Hospital of Philadelphia

NISHISAKI@email.chop.edu

267-426-0665

Study Officials

• Akira Nishisaki, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: June 21, 2017
• Study Start: January 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: April 9, 2021
• Results First Posted: June 29, 2020

Record last verified: 2021-03

Locations

SG (1); CA (1); US (8)