Using a bedside decision-support tool to shorten ventilator time after pediatric heart surgery
Official title: Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Run by Boston Children's Hospital · NCT05687292 · Data updated 2026-11-12
This test will see if a computer decision-support tool can help clinicians shorten the time children under 12 spend on a ventilator after congenital heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 12 Years |
| Sex | All |
| Enrollment | 330 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | November 18, 2024 |
| Main results expected | November 18, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT05687292 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 12 years old who are in the Cardiac ICU at Boston Children's Hospital, post-congenital heart surgery, and receiving mechanical ventilation for 48 hours or more are ideal candidates.
✕Probably not a fit
Premature infants (<37 weeks' gestation), infants weighing under 2 kg, and patients who are baseline ventilator-dependent via tracheostomy or noninvasive support are excluded and unlikely to benefit from this CDSS.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project uses a clinical decision support system (CDSS) embedded in the T3 platform that continuously pulls physiologic monitor, ventilator, and lab data and applies predictive algorithms (IDO2, IVCO2, IPH) to flag readiness for weaning. Eligible patients are children under 12 who have received mechanical ventilation for at least 48 hours after congenital cardiac surgery in the Cardiac ICU, with exclusions for prematurity, very low weight, or baseline ventilator dependence. Clinicians may choose to follow the CDSS recommendations; patients exposed to the CDSS will be compared with a historical cohort to measure changes in mechanical ventilation duration and extubation outcomes. The study is designed to detect whether using continuous-data analytics at the bedside can shorten ventilation time without increasing reintubation or other complications.
Why it matters
Potential benefit: If successful, the CDSS could reduce time on mechanical ventilation, lower ventilation-related complications, and shorten ICU stays for post-operative pediatric heart patients.
How similar studies have gone: Retrospective analyses of the IDO2 and IVCO2 algorithms showed associations with successful extubation, but applying these predictive tools prospectively in a bedside CDSS for weaning is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Daniel Hames, MD — Boston Children's Hospital
- Study coordinator: Daniel L Hames, MD
- Email: daniel.hames@cardio.chboston.org
- Phone: 6173554023
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.