MedPath

Tracheal Intubation Coaching in NICUs

Not Applicable
Completed
Conditions
Intubation;Difficult
Intubation Complication
Failed or Difficult Intubation, Sequela
Interventions
Device: VL Coaching training using C-MAC video laryngoscope
Registration Number
NCT03194503
Lead Sponsor
Children's Hospital of Philadelphia
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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1512
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AttendingsVL Coaching training using C-MAC video laryngoscopeStudy 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.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years2 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 Outcome Measures
NameTimeMethod
Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching18 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.

Trial Locations

Locations (10)

Penn State Health Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

University of Colorado Hospital

🇺🇸

Aurora, Colorado, United States

Dartmouth-Hitchcock Medical Center

🇺🇸

Lebanon, New Hampshire, United States

University of California San Diego Jacobs Medical Center

🇺🇸

La Jolla, California, 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

CHU Sainte-Justine

🇨🇦

Montréal, Quebec, Canada

University of Washington Medical Center

🇺🇸

Seattle, Washington, United States

KK Women's and Children's Hospital

🇸🇬

Singapore, Singapore

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