Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study (SMART PICU)

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).

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication
• Intervention / Treatment: Other: Smart Checklist

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hayley Buffman, MPH; Phone Number: 215-590-1000; Email: buffmanh@chop.edu
• Study Contact Backup: Name: Akira Nishisaki, MD, MSCE; Phone Number: 215-590-1000; Email: nishisaki@chop.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas
      • Contact: Jill Gassaway; Phone Number: 501-364-2862; Email: gassawayja@archildrens.org
      • Principal Investigator: Ronald C Sanders Jr, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Robert E Nobles, DrPH, MPH; Phone Number: 404-727-3889; Email: robert.e.nobles@emory.edu
      • Contact: Anna Lum; Phone Number: 404.785.5212; Email: Anna.lum@choa.org
      • Principal Investigator: Mark Mai, MD, MHS
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Kristi DeHaai, MS, CIP; Phone Number: 402-559-9991; Email: krdehaai@unmc.edu
      • Principal Investigator: Andrea Talukdar, MD
  • Ohio
    • Akron, Ohio, United States, 44308
      • Recruiting
      • Akron Children's Hospital
      • Contact: Michelle Jacobs, MA CIP CCRP; Phone Number: 330-543-4969; Email: mjacobs@akronchildrens.org
      • Principal Investigator: Christopher Page-Goertz, MD
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Hasbro Children's Hospital
      • Contact: Claire Walker; Phone Number: 401-444-8285
      • Principal Investigator: Lee A Polikoff, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Joanna Faulconer; Phone Number: 434-982-1855; Email: Jld6p@virginia.edu
      • Principal Investigator: Michelle Adu-Darko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All patients intubated in the PICU at participating sites

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of invasive mechanical ventilation	Duration of invasive mechanical ventilation (time to extubation or tracheostomy)	During the ICU stay, up to 180 days
Duration of ICU stay	Duration of ICU stay (days)	During the ICU stay, up to 180 days
ICU mortality	ICU mortality (all cause)	During the ICU stay, up to 180 days

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Akira Nishisaki, MD, MSCE, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Pediatric; Intubation; PICU
• Other Study ID Numbers: 23-021168; R01HS029188 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Data will be available after study completion
• IPD Sharing 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No