Clinical trial NCT05687292: Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children
Official title: Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Congenital Heart Disease
Keywords: cardiac surgery
congenital heart disease
critical care
pediatrics
mechanical ventilation
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Brett Boyer Foundation
First posted: 2023-01-18
Enrollment: 330
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates, infants, and children with congenital heart disease receiving mechanical ventilation after cardiac surgery.

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).

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

Primary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: Up to 28 days after surgery
Secondary outcomes:
measure: Unplanned extubation
timeFrame: From date of surgery until date of first documented extubation, assessed up to 28 days
measure: Unplanned use of noninvasive ventilation
timeFrame: Within 48 hours of extubation
measure: Unplanned reintubation
timeFrame: Within 48 hours of extubation
measure: Adherence rate by clinical team to CDSS recommendations
timeFrame: From date of CDSS initiation until date of first documented extubation, assessed up to 28 days
Other outcomes:
measure: Cardiac intensive care unit length of stay
timeFrame: From date of surgery until the date of initial discharge from the cardiac intensive care unit, assessed up to 52 weeks
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Daniel Hames, MD
role: PRINCIPAL_INVESTIGATOR
References: