NCT07114510 · Children's Hospital of Philadelphia
Optimal Ventilation for Cardiac Arrest
(OPTI-VENT)
What this study is about
Pediatric cardiac arrest is a life-threatening problem affecting \>15,000 hospitalized children each year. Less than half of these children survive to hospital discharge, and neurologic morbidity is common among survivors.
View original scientific description
Pediatric cardiac arrest is a life-threatening problem affecting \>15,000 hospitalized children each year. Less than half of these children survive to hospital discharge, and neurologic morbidity is common among survivors. The objective of this study is to evaluate the effectiveness of the OPTI-VENT bundle to improve survival to discharge with favorable neurological outcome (Pediatric Cerebral Performance Category Score 1-2 or no change from baseline) among children receiving at least 1 minute of CPR.
Interventions
OTHER
OPTI-VENT Bundle
Provider Education: During a brief (\<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
OTHER
Transition
There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
OTHER
None - control
Control - no intervention
Primary outcome measures
Survival with a favorable neurologic outcome
Time frame: From baseline (assessed prior to admission, or new in-hospital baseline assessed no more than 30 days prior to cardiac arrest for patients hospitalized >90 days) to the assessment at hospital discharge, estimated average of 6-12 months
Survival to hospital discharge with a favorable neurologic outcome (Pediatric Cerebral Performance Category (PCPC) score (scored on a scale of 1-6) at hospital discharge of 1 (normal), 2 (mild disability) or no worse than baseline). Percentage of subjects in control vs. intervention will be compared.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Orange, California
- Palo Alto, California
- Denver, Colorado
- Wilmington, Delaware
- Atlanta, Georgia
- Indianapolis, Indiana
- Iowa City, Iowa
- Boston, Massachusetts
- St Louis, Missouri
- New Hyde Park, New York
- Chapel Hill, North Carolina
- Cincinnati, Ohio
And 7 more locations — see the full list below.
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Utah, Villanova University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2025 · Source of record for eligibility and locations