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

Active, not recruiting

• Conditions: Congenital Heart Disease
• Interventions: Device: Clinical decision support system (CDSS) for ventilator weaning

• Registration Number: NCT05687292
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Prolonged mechanical ventilation (MV) in children with congenital heart disease (CHD) is associated with morbidity and mortality. There is no standard approach to weaning MV in CHD patients. Similarly, extubation failure is associated with morbidity and mortality, and there is no existing method for predicting extubation success in CHD patients. The overarching aim of this study is to use a novel clinical decision support system (CDSS) informed by continuous data streams and risk analytics algorithms to facilitate shorter MV duration.

The CDSS will be built into the T3 Visualization Platform (T3). T3 continuously tracks all inputs from a patient's existing physiologic monitors, ventilator, and laboratory values from the electronic medical record. T3 then graphically displays the data on a single bedside computer/monitor that is updated every 5 seconds. The platform includes three FDA 510(k)-cleared predictive analytics algorithms for estimating the risk of low cardiac output (IDO2), inadequate ventilation (IVCO2), and acidosis (IPH). The investigators for this study have previously evaluated IDO2 and IVCO2 in a retrospective cohort of children receiving MV for greater than or equal to 48 hours following cardiac surgery. This study identified that patients with a low IDO2 and IVCO2 had a higher probability of remaining extubated without the need for reintubation or unplanned use of noninvasive ventilation in the 48 hours following extubation.

The CDSS will be designed to prompt discussion around timing of ventilator weaning, extubation readiness assessments, and extubation. Recommendations will be informed by the continuous monitoring of a patient and based on trends in vital signs and the risk analytics algorithms.

This study will be a single center, nonrandomized before and after study with additional quasi-experimental design component using interrupted time-series analysis (with retrospective evaluation of pre-intervention and prospective data collection post-intervention).

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-18
• Study Start: 2024-11-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-11-18
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 330

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CDSS Ventilator Weaning Group	Clinical decision support system (CDSS) for ventilator weaning	This group will be exposed to the CDSS to inform weaning and discontinuation of mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
Duration of Mechanical Ventilation	Up to 28 days after surgery	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 Outcome Measures

Name	Time	Method
Adherence rate by clinical team to CDSS recommendations	From date of CDSS initiation until date of first documented extubation, assessed up to 28 days	Clinical team follows recommendations provided by the CDSS for ventilator weaning, extubation readiness test performance, and extubation
Unplanned reintubation	Within 48 hours of extubation	Patient requires unplanned replacement of breathing tube
Unplanned use of noninvasive ventilation	Within 48 hours of extubation	Patient extubated to room air requiring escalation to positive pressure ventilation
Unplanned extubation	From date of surgery until date of first documented extubation, assessed up to 28 days	Unplanned extubation during CDSS activation; Occurring between return from surgery and initial planned extubation

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States