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

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Intubation Complication

Treatments: Other: Smart Checklist

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06085326

R01HS029188 (U.S. AHRQ Grant/Contract)

23-021168

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: Under 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients intubated in the PICU at participating sites

Exclusion criteria

Endotracheal tube exchanges, as this represents a distinct procedure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Pre-Intervention Phase

No Intervention group

Description:

PICU patients who are intubated without the Smart checklist

Post-Intervention Phase

Active Comparator group

Description:

PICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit.

Treatment:

Other: Smart Checklist