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

Last updated: November 8, 2024
Sponsor: Children's Hospital of Philadelphia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Smart Checklist

Clinical Study ID

NCT06085326
23-021168
R01HS029188
  • Ages < 19
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

All patients intubated in the PICU at participating sites

Exclusion

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Smart Checklist
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
September 30, 2028

Study Description

More than 20% of the critically ill children who require tracheal intubation suffer from adverse events. To reduce the adverse event risk, and optimize bedside team performance investigators will implement a digitized Smart Checklist that has three specific features: (1) prompts based on patient characteristics, (2) direct display of difficult airway status and airway information, and (3) high-risk warning based on predictive analytics.

This is a stepped-wedge cluster randomized trial of PICU patients who are intubated across 6 participating hospitals to determine if the Smart Checklist reduces the incidence of adverse tracheal intubation associated events.

The primary objective of this study is to determine the clinical impact of the personalized, dynamic, adaptive Smart Checklist implementation on the occurrence of Adverse Airway Outcomes (AAOs) in the pediatric ICU. The secondary objective is to characterize work systems and processes that affect clinical impact of the digitized Smart Checklist.

Connect with a study center

  • University of Arkansas

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Akron Children's Hospital

    Akron, Ohio 44308
    United States

    Active - Recruiting

  • Hasbro Children's Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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