Best breathing strategy during pediatric cardiac arrest
OPTImal Ventilation to Improve Pediatric Cardiac Arrest Outcomes (OPTI-VENT)
This study will test whether the OPTI-VENT bundle of breathing adjustments during CPR helps children who have a cardiac arrest in the hospital survive to discharge with good brain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1530 (estimated) |
| Ages | 37 Weeks to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 20 sites (Orange, California and 19 other locations) |
| Trial ID | NCT07114510 on ClinicalTrials.gov |
What this trial studies
The trial enrolls children who receive at least one minute of in-hospital CPR and who have an invasive airway in place at the start of CPR or have an airway placed within the first five minutes. Enrolled patients are allocated to receive the OPTI-VENT bundle, a transition strategy, or standard care, and clinical teams follow the assigned ventilation approach during resuscitation. The primary outcome is survival to hospital discharge with a favorable neurological outcome (Pediatric Cerebral Performance Category Score 1–2 or no change from baseline). The study is conducted across several large U.S. pediatric centers to capture real-world resuscitation events.
Who should consider this trial
Good fit: Children in the hospital who have a cardiac arrest, receive at least one minute of CPR, and have an invasive airway in place at the start of CPR or placed within the first five minutes are eligible.
Not a fit: Children who receive CPR as part of end-of-life care, who were already declared brain dead before the event, who were admitted because of an out-of-hospital arrest, or who were on veno-arterial ECMO at the start of CPR are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the OPTI-VENT bundle could increase the number of children who leave the hospital after cardiac arrest with good neurological function.
How similar studies have performed: Ventilation-focused resuscitation strategies have physiologic rationale and mixed findings in adults, but randomized pediatric evidence is limited, so the OPTI-VENT bundle is a relatively novel pediatric approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Invasive airway in place at the start of CPR or airway placed within the first 5 minutes * Received at least 1 minute of CPR. Exclusion Criteria: * Lack of commitment to aggressive ICU therapies (e.g., CPR performed as part of end-of-life care. * Brain death determination prior to the CPR event. * Out-of-hospital cardiac arrest was the reason for initial admission to the hospital (known poor outcomes). * Supported by Veno-Arterial Extra Corporeal Membrane Oxygenation at the start of CPR
Where this trial is running
Orange, California and 19 other locations
- Choc — Orange, California, United States (Recruiting)
- Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States (Recruiting)
- Children's Hospital Colorado — Denver, Colorado, United States (Recruiting)
- Nemours Children's Health — Wilmington, Delaware, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Riley Children's Health — Indianapolis, Indiana, United States (Recruiting)
- Stead Family Children's Hospital — Iowa City, Iowa, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
- Cohen Children's Medical Center — New Hyde Park, New York, United States (Recruiting)
- UNC Children's Hospital — Chapel Hill, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Dell Children's Medical Center — Austin, Texas, United States (Recruiting)
- Medical City Children's Hospital — Dallas, Texas, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Children's Hospital of Richmond at VCU — Richmond, Virginia, United States (Recruiting)
- Seattle Children's — Seattle, Washington, United States (Recruiting)
- Children's Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Robert Sutton, MD, MSCE — Children's Hospital of Philadelphia
- Study coordinator: CHOP RSC Clinical Research Program Manager
- Email: grahamk1@chop.edu
- Phone: 215-590-1859
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.