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

Not Applicable

Recruiting

• Conditions: Intubation Complication
• Interventions: Other: Smart Checklist

• Registration Number: NCT06085326
• Lead Sponsor: Children's Hospital of Philadelphia

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).

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 Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2028-06-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

All patients intubated in the PICU at participating sites

Exclusion Criteria

Endotracheal tube exchanges, as this represents a distinct procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Post-Intervention Phase	Smart Checklist	PICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit.

Primary Outcome Measures

Name	Time	Method
Adverse Airway Outcomes	During the intubation procedure and up to 20 minutes after procedure	A composite outcome for adverse events or acute oxygen desaturation \<80%

Secondary Outcome Measures

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

Trial Locations

Locations (6)

University of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States

Hasbro Children's Hospital; 🇺🇸 Providence, Rhode Island, United States