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Completed

NCT Number: NCT03194503

Tracheal Intubation Coaching in NICUs

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.

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Key information

Age range

22 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine, Montreal, Quebec, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years

    Time frame: 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.

Secondary outcomes

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

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Washington

Registry information

Official study title

Improving Safety and Quality of Tracheal Intubations in Neonatal ICUs

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2017
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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