Recruiting

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06085326

Conditions

Intubation Complication

Eligibility Criteria

Sex: All

Age: 0 - 19

Healthy Volunteers: Not accepted

Interventions

Smart Checklist

Study Details

Brief summary:

The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs).

Conditions

Intubation Complication

Study ID

NCT06085326

Start date

Oct 1, 2023

Status verified date

Oct, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

All patients intubated in the PICU at participating sites

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Pre-Intervention Phase

PICU patients who are intubated without the Smart checklist

active comparator: Post-Intervention Phase

PICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit.

Interventions

Smart Checklist

The digitized Smart Checklist includes three new features that currently do not exist on a paper checklist: 1) decision support prompts based on patient-provider dyad characteristics, 2) real time display of patient pertinent airway information from the EHR, and 3) high-risk warning alerts based on predictive analytics with potential explanatory factors from the model.

Primary outcome measure

  • Adverse Airway Outcomes [ Time Frame: During the intubation procedure and up to 20 minutes after procedure ]

Central Contacts and Locations

Central contacts

Akira Nishisaki, MD, MSCE

215-590-1000nishisaki@chop.edu

Hayley Buffman, MPH

215-590-1000buffmanh@chop.edu

Locations

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Jill Gassaway

501-364-2862gassawayja@archildrens.org

Principal Investigator:

Ronald C Sanders Jr, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Robert E Nobles, DrPH, MPH

404-727-3889robert.e.nobles@emory.edu

Anna Lum

404.785.5212Anna.lum@choa.org

Principal Investigator:

Mark Mai, MD, MHS

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Kristi DeHaai, MS, CIP

402-559-9991krdehaai@unmc.edu

Principal Investigator:

Andrea Talukdar, MD

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Michelle Jacobs, MA CIP CCRP

330-543-4969mjacobs@akronchildrens.org

Principal Investigator:

Christopher Page-Goertz, MD

Hasbro Children's Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Claire Walker

401-444-8285

Principal Investigator:

Lee A Polikoff, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Joanna Faulconer

434-982-1855Jld6p@virginia.edu

Principal Investigator:

Michelle Adu-Darko, MD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • Pediatric
  • Intubation
  • PICU
  • Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2025-10-20.