Recruiting

CDSS

Sponsor:

Boston Children's Hospital

Code:

NCT05687292

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

Interventions

Clinical decision support system (CDSS) for ventilator weaning

Study Details

Brief summary:

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.

Conditions

Congenital Heart Disease

Study ID

NCT05687292

Start date

Nov 18, 2024

Status verified date

May, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Nov 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Premature infants (<37 weeks' gestation)
  • Weight < 2kg
  • Baseline ventilator (via tracheostomy) or noninvasive positive pressure dependence

Study Design

Enrollment

330 participants

Anticipated

Interventions and Outcome Measures

Arms

CDSS Ventilator Weaning Group

This group will be exposed to the CDSS to inform weaning and discontinuation of mechanical ventilation.

Interventions

Clinical decision support system (CDSS) for ventilator weaning

A 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.

Primary outcome measure

  • Duration of Mechanical Ventilation [ Time Frame: Up to 28 days after surgery ]

Central Contacts and Locations

Central contacts

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Boston Children's Hospital

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • cardiac surgery
  • congenital heart disease
  • critical care
  • pediatrics
  • mechanical ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-05-12.