About this trial
The goal of this study is to evaluate the impact of a clinical decision support system (CDSS) in children receiving mechanical ventilation (MV) after surgery for congenital heart disease (CHD). The main question it aims to answer is:
-What is the impact of a CDSS designed to facilitate weaning and discontinuation of MV on the duration of MV in post-operative congenital cardiac surgery patients?
Participants will be identified as eligible to initiate weaning from mechanical ventilation. Providers will decide whether or not to initiate weaning based on recommendations provided by the CDSS. Researchers will compare patients exposed to the CDSS with a historical cohort to see if the CDSS facilitated a decrease in MV duration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children < 12 years old
Post-cardiac surgery
Receiving mechanical ventilation for ≥ 48 hours in the Cardiac Intensive Care Unit at Boston Children's Hospital following surgery
Disqualifiers
Premature infants (<37 weeks' gestation)
Weight < 2kg
Baseline ventilator (via tracheostomy) or noninvasive positive pressure dependence
Trial population
Neonates, infants, and children with congenital heart disease receiving mechanical ventilation after cardiac surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Clinical decision support system (CDSS) for ventilator weaning
DeviceA clinical decision support system (CDSS) will be integrated into a software program (the T3 platform) that is present on all patient bedside computers. The T3 platform is a tool that compiles data from a patient's existing physiologic monitors, ventilator, and laboratory results and graphically displays them on a bedside monitor. The CDSS will be active on all patients receiving mechanical ventilation, but primary use and evaluation will focus on patients meeting study criteria. Twice daily (on morning rounds and evening rounds), patients will be screened for eligibility. During each rounds, teams will review the CDSS and associated risk analytics data used to inform the associated recommendations for ventilator weaning, extubation readiness assessment, and extubation. The clinical team will consider the CDSS in decision making around ventilator weans. If the decision is made not to follow the CDSS recommendations, the clinician will complete a brief survey with rationale.
Treatment groups
Trial outcomes
Primary outcomes
Duration of Mechanical Ventilation
Measured in days; Obtained from date/time of initial extubation minus date/time of admission from surgery, divided by 24 to give an exact determination of days
Secondary outcomes
Unplanned extubation
Unplanned extubation during CDSS activation; Occurring between return from surgery and initial planned extubation
Unplanned use of noninvasive ventilation
Patient extubated to room air requiring escalation to positive pressure ventilation
Unplanned reintubation
Patient requires unplanned replacement of breathing tube
Adherence rate by clinical team to CDSS recommendations
Clinical team follows recommendations provided by the CDSS for ventilator weaning, extubation readiness test performance, and extubation
Other outcomes
Cardiac intensive care unit length of stay
Measured in days
Sponsors and contacts
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Boston Children's Hospital
Lead sponsor
The Brett Boyer Foundation
Collaborator