Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 3,000
- Locations
- 12
- Primary Endpoint
- Adverse Airway Outcomes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 19 Years (Child, Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Adverse Airway Outcomes
Time Frame: During the intubation procedure and up to 20 minutes after procedure
A composite outcome for adverse events or acute oxygen desaturation \<80%
Secondary Outcomes
- Duration of invasive mechanical ventilation(During the ICU stay, up to 180 days)
- Duration of ICU stay(During the ICU stay, up to 180 days)
- ICU mortality(During the ICU stay, up to 180 days)