Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
NCT ID: NCT06085326
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3000 participants
INTERVENTIONAL
2023-10-01
2028-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Pre-Intervention Phase
PICU patients who are intubated without the Smart checklist
No interventions assigned to this group
Post-Intervention Phase
PICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Akira Nishisaki, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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University of Arkansas
Little Rock, Arkansas, United States
Emory University
Atlanta, Georgia, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Akron Children's Hospital
Akron, Ohio, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Claire Walker
Role: primary
Other Identifiers
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23-021168
Identifier Type: -
Identifier Source: org_study_id
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