Clinical trial NCT06085326: Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Official title: Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubation Complication
Keywords: Pediatric
Intubation
PICU
Safety
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-10-16
Enrollment: 3000
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

All patients intubated in the PICU at participating sites

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure

Primary outcomes:
measure: Adverse Airway Outcomes
timeFrame: During the intubation procedure and up to 20 minutes after procedure
Secondary outcomes:
measure: Duration of invasive mechanical ventilation
timeFrame: During the ICU stay, up to 180 days
measure: Duration of ICU stay
timeFrame: During the ICU stay, up to 180 days
measure: ICU mortality
timeFrame: During the ICU stay, up to 180 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Akira Nishisaki, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: