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Tracheal Intubation Coaching in NICUs

NCT03194503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1512

Last updated 2021-04-09

Study results available
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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

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Akira Nishisaki, MD, MSCE · Children's Hospital of Philadelphia

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Device
Yes

Countries

  • United States
  • Canada
  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194503 on ClinicalTrials.gov