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

Intubation Complication Clinical Trial

— SMART PICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085326
• Other study ID #: 23-021168
• Secondary ID: R01HS029188
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: October 2023
• Source: Children's Hospital of Philadelphia
• Contact: Akira Nishisaki, MD, MSCE
• Phone: 215-590-1000
• Email: nishisaki[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

Inclusion Criteria:

All patients intubated in the PICU at participating sites

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure

Related Conditions & MeSH terms

• Intubation Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	Emory University	Atlanta	Georgia
United States	University of Virginia	Charlottesville	Virginia
United States	University of Arkansas	Little Rock	Arkansas
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of invasive mechanical ventilation	Duration of invasive mechanical ventilation (time to extubation or tracheostomy)	During the ICU stay, up to 180 days
Secondary	Duration of ICU stay	Duration of ICU stay (days)	During the ICU stay, up to 180 days
Secondary	ICU mortality	ICU mortality (all cause)	During the ICU stay, up to 180 days