Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06085326
Status
Recruiting

Conditions

  • Intubation Complication

Eligibility Criteria

Sex
ALL
Age
N/A - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Smart Checklist — OTHER
    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.

Study Details

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).

Key Dates

Start date
Oct 1, 2023
Status verified
Oct 2025
Primary completion
Jun 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of ArkansasLittle RockArkansas72205
Jill Gassaway
501-364-2862
Ronald C Sanders Jr, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Robert E Nobles, DrPH, MPH
404-727-3889
Anna Lum
404.785.5212
Mark Mai, MD, MHS (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Kristi DeHaai, MS, CIP
402-559-9991
Andrea Talukdar, MD (PRINCIPAL_INVESTIGATOR)
Akron Children's HospitalAkronOhio44308
Michelle Jacobs, MA CIP CCRP
330-543-4969
Christopher Page-Goertz, MD (PRINCIPAL_INVESTIGATOR)
Hasbro Children's HospitalProvidenceRhode Island02903
Claire Walker
401-444-8285
Lee A Polikoff, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Joanna Faulconer
434-982-1855
Michelle Adu-Darko, MD (PRINCIPAL_INVESTIGATOR)

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