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

NCT ID: NCT05687292

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2027-03-01

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).

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CDSS Ventilator Weaning Group

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

Clinical decision support system (CDSS) for ventilator weaning

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Brett Boyer Foundation

UNKNOWN

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniel Hames

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Hames, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P00044253

Identifier Type: -

Identifier Source: org_study_id