Clinical trial NCT03194503: Tracheal Intubation Coaching in NICUs
Official title: Improving Safety and Quality of Tracheal Intubations in Neonatal ICUs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed or Difficult Intubation, Sequela
Intubation;Difficult
Intubation Complication
Keywords: Intubation
Video Laryngoscope
Coaching/training
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-06-21
Enrollment: 1512
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching
timeFrame: 18 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Jacobs Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Children's Hospital
state: Connecticut
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Akira Nishisaki, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: