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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06085326
Acronym
SMART PICU
Enrollment
3000
Registered
2023-10-16
Start date
2023-10-01
Completion date
2028-09-30
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

Keywords

Pediatric, Intubation, PICU, Safety

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.

Interventions

OTHERSmart 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No

Inclusion criteria

All patients intubated in the PICU at participating sites

Exclusion criteria

Endotracheal tube exchanges, as this represents a distinct procedure

Design outcomes

Primary

MeasureTime frameDescription
Adverse Airway OutcomesDuring the intubation procedure and up to 20 minutes after procedureA composite outcome for adverse events or acute oxygen desaturation \<80%

Secondary

MeasureTime frameDescription
Duration of invasive mechanical ventilationDuring the ICU stay, up to 180 daysDuration of invasive mechanical ventilation (time to extubation or tracheostomy)
Duration of ICU stayDuring the ICU stay, up to 180 daysDuration of ICU stay (days)
ICU mortalityDuring the ICU stay, up to 180 daysICU mortality (all cause)

Countries

United States

Contacts

Primary ContactAkira Nishisaki, MD, MSCE
nishisaki@chop.edu215-590-1000
Backup ContactHayley Buffman, MPH
buffmanh@chop.edu215-590-1000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026