NCT06085326

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Oct 2023Sep 2028

Study Start

First participant enrolled

October 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

4.8 years

First QC Date

October 11, 2023

Last Update Submit

October 16, 2025

Conditions

Intubation Complication

Keywords

PediatricIntubationPICUSafety

Outcome Measures

Primary Outcomes (1)

  • Adverse Airway Outcomes

    A composite outcome for adverse events or acute oxygen desaturation \<80%

    During the intubation procedure and up to 20 minutes after procedure

Secondary Outcomes (3)

  • Duration of invasive mechanical ventilation

    During the ICU stay, up to 180 days

  • Duration of ICU stay

    During the ICU stay, up to 180 days

  • ICU mortality

    During the ICU stay, up to 180 days

Study Arms (2)

Pre-Intervention Phase

NO INTERVENTION

PICU patients who are intubated without the Smart checklist

Post-Intervention Phase

ACTIVE COMPARATOR

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

Other: Smart Checklist

Interventions

Smart ChecklistOTHER

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.

Post-Intervention Phase

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All patients intubated in the PICU at participating sites

You may not qualify if:

  • Endotracheal tube exchanges, as this represents a distinct procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Study Officials

  • Akira Nishisaki, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Akira Nishisaki, MD, MSCE

CONTACT

215-590-1000nishisaki@chop.edu

Hayley Buffman, MPH

CONTACT

215-590-1000buffmanh@chop.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 16, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

The PI will share unique research resources developed through this Agency for Healthcare Research and Quality (AHRQ)-funded grant to enhance the value and further the advancement of research. The PI will make data available after study completion and in accordance with AHRQ policies. The data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or demonstration of IRB exemption per institutional policy. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed

Time Frame
Data will be available after study completion
Access Criteria
The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed

Locations

US(6)