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

NCT ID: NCT06085326

Last Updated: 2025-10-17

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2028-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre-Intervention Phase

PICU patients who are intubated without the Smart checklist

Group Type NO_INTERVENTION

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.

Group Type ACTIVE_COMPARATOR

Smart Checklist

Intervention Type 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.

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

All patients intubated in the PICU at participating sites

Exclusion Criteria

Endotracheal tube exchanges, as this represents a distinct procedure
Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Akron Children's Hospital

Akron, Ohio, United States

Site Status RECRUITING

Hasbro Children's Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Akira Nishisaki, MD, MSCE

Role: CONTACT

215-590-1000

Hayley Buffman, MPH

Role: CONTACT

215-590-1000

Facility Contacts

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Jill Gassaway

Role: primary

501-364-2862

Robert E Nobles, DrPH, MPH

Role: primary

404-727-3889

Anna Lum

Role: backup

404.785.5212

Kristi DeHaai, MS, CIP

Role: primary

402-559-9991

Michelle Jacobs, MA CIP CCRP

Role: primary

330-543-4969

Claire Walker

Role: primary

401-444-8285

Joanna Faulconer

Role: primary

434-982-1855

Other Identifiers

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R01HS029188

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

23-021168

Identifier Type: -

Identifier Source: org_study_id

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