Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smart Checklist.
- Who it may be relevant to
- Registry conditions: Intubation Complication. Basic parameters: up to 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- Adverse Airway Outcomes [Time frame: During the intubation procedure and up to 20 minutes after procedure]
Secondary outcome measures (3)
- Duration of invasive mechanical ventilation [Time frame: During the ICU stay, up to 180 days]
- Duration of ICU stay [Time frame: During the ICU stay, up to 180 days]
- ICU mortality [Time frame: During the ICU stay, up to 180 days]
Eligibility criteria
Inclusion criteria
All patients intubated in the PICU at participating sites
Exclusion criteria
Endotracheal tube exchanges, as this represents a distinct procedure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 6 centers
- University of Arkansas — Little Rock
- Emory University — Atlanta
- University of Nebraska Medical Center — Omaha
- Akron Children's Hospital — Akron
- Hasbro Children's Hospital — Providence
- University of Virginia — Charlottesville
Identifiers
NCT: NCT06085326 · 23-021168 · R01HS029188