Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

Recruiting

• Conditions: Intubation Complication; Failed or Difficult Intubation, Sequela; Intubation; Difficult

• Registration Number: NCT02493478
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences.

Detailed Description

This study will evaluate local pediatric intensive care unit (PICU), cardiac intensive care unit (CICU) and neonatal intensive care unit (NICU) as well as EDs and delivery room (DR) practice, and benchmark against other PICUs, CICUs, NICUs, DRs and EDs as a part of Multi-Center Airway Safety collaborative network (NEAR4KIDS).

The goal of the study is to utilize collected benchmarked data to improve local practice. In order to develop this quality improvement (QI) intervention and collaboration, it is necessary to collect baseline data to describe current practice and to continuously evaluate the effectiveness of any QI intervention.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150000

Inclusion Criteria

• Primary advanced airway events (on patients of all ages) in the PICU, CICU, NICU, DR and ED including: Tracheal Intubation, Laryngeal mask placement, Emergency tracheostomy and/or cricothyrotomy
• Failed extubation attempts or unplanned extubations that require re-intubation will be considered a new primary intubation.

Exclusion Criteria

• Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in number of tracheal intubation associated events (TIAEs)	participants will be followed for the duration of their hospital stay, an expected average of 4 weeks	The number of TIAEs during primary tracheal intubation will be compared to any TIAEs documented during subsequent intubation attempts.

Trial Locations

Locations (86)

Children's of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Children's Hospital of Central California; 🇺🇸 Madera, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Yale New Haven Children's Hospital; 🇺🇸 New Haven, Connecticut, United States

Yale-New Haven Children's Hospital; 🇺🇸 New Haven, Connecticut, United States

Nemours Children's Health, Delaware; 🇺🇸 Wilmington, Delaware, United States

Miami Children's Hospital; 🇺🇸 Miami, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

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