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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Premature infants (<37 weeks' gestation)

Weight < 2kg

Baseline ventilator (via tracheostomy) or noninvasive positive pressure dependence

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

330 Participants
are divided into 1 treatment group
Group A: CDSS Ventilator Weaning Group1 intervention

Trial outcomes

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

Time frame
Up to 28 days after surgery

Secondary outcomes

1

Unplanned extubation

Unplanned extubation during CDSS activation; Occurring between return from surgery and initial planned extubation

Time frame
From date of surgery until date of first documented extubation, assessed up to 28 days
2

Unplanned use of noninvasive ventilation

Patient extubated to room air requiring escalation to positive pressure ventilation

Time frame
Within 48 hours of extubation
3

Unplanned reintubation

Patient requires unplanned replacement of breathing tube

Time frame
Within 48 hours of extubation
4

Adherence rate by clinical team to CDSS recommendations

Clinical team follows recommendations provided by the CDSS for ventilator weaning, extubation readiness test performance, and extubation

Time frame
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

Measured in days

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

The Brett Boyer Foundation

Collaborator