Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children

NCT05687292 | Recruiting FDA Device

• 1 other identifier: P00044253
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 28 days after surgery

Secondary Outcomes (4)

• Unplanned extubation

  From date of surgery until date of first documented extubation, assessed up to 28 days

• Unplanned use of noninvasive ventilation

  Within 48 hours of extubation

• Unplanned reintubation

  Within 48 hours of extubation

• Adherence rate by clinical team to CDSS recommendations

  From date of CDSS initiation until date of first documented extubation, assessed up to 28 days

Other Outcomes (1)

• Cardiac intensive care unit length of stay

  From date of surgery until the date of initial discharge from the cardiac intensive care unit, assessed up to 52 weeks

Study Arms (1)

CDSS Ventilator Weaning Group

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

Device: Clinical decision support system (CDSS) for ventilator weaning

Interventions

Clinical decision support system (CDSS) for ventilator weaning DEVICE

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.

CDSS Ventilator Weaning Group

Eligibility Criteria

• Age: 1 Day - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates, infants, and children with congenital heart disease receiving mechanical ventilation after cardiac surgery.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• The Brett Boyer Foundation: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Daniel Hames, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel L Hames, MD

CONTACT

6173554023; daniel.hames@cardio.chboston.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 18, 2023
• Study Start: November 18, 2024
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)