Using a bedside decision-support tool to shorten ventilator time after pediatric heart surgery
Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
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 |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 1 Day to 12 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05687292 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.