Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Boston Children's Hospital
- Study ID
- NCT05687292
- Status
- Recruiting
Conditions
- Congenital Heart Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Day - 12 Years
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.
Key Dates
- Start date
- Nov 18, 2024
- Status verified
- May 2026
- Primary completion
- Nov 18, 2026
- Completion
- Mar 1, 2027
Study Design
- Enrollment
- 330 participants (estimated)
Arms
- Arm: CDSS Ventilator Weaning GroupThis group will be exposed to the CDSS to inform weaning and discontinuation of mechanical ventilation.
Primary Outcome Measure
Duration of Mechanical Ventilation [ Time Frame: Up to 28 days after surgery ]
Central Contacts
- Daniel L Hames, MD6173554023
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 |
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