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

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT06085326

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

3,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

500

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication	Other: Smart Checklist	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2028

Anticipated Study Completion Date :

Sep 30, 2028

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients intubated in the PICU at participating sites

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas	Little Rock	Arkansas	United States	72205
2	Emory University	Atlanta	Georgia	United States	30322
3	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
4	Akron Children's Hospital	Akron	Ohio	United States	44308
5	Hasbro Children's Hospital	Providence	Rhode Island	United States	02903
6	University of Virginia	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

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

Investigators

Principal Investigator: Akira Nishisaki, MD, MSCE, Children's Hospital of Philadelphia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital of Philadelphia

ClinicalTrials.gov Identifier:

NCT06085326

Other Study ID Numbers:

23-021168
R01HS029188

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Children's Hospital of Philadelphia

Study Results

No Results Posted as of Oct 16, 2023