NCT Number: NCT06085326
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).
Interested in participating?
Request InfoUp to 19 year
All sexes
Interventional
Not applicable
University of Arkansas, Little Rock, Arkansas, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients intubated in the PICU at participating sites
Exclusion criteria
Endotracheal tube exchanges, as this represents a distinct procedure
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.
Time frame: During the intubation procedure and up to 20 minutes after procedure
A composite outcome for adverse events or acute oxygen desaturation <80%
Time frame: During the ICU stay, up to 180 days
Duration of invasive mechanical ventilation (time to extubation or tracheostomy)
Time frame: During the ICU stay, up to 180 days
Duration of ICU stay (days)
Time frame: During the ICU stay, up to 180 days
ICU mortality (all cause)
Contact information is provided by the study sponsor or research team.
Akira Nishisaki, MD, MSCE
CONTACT
Hayley Buffman, MPH
CONTACT
Children's Hospital of Philadelphia
Other
Acronym: SMART PICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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