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NCT Number: NCT07114510

Optimal Ventilation for Cardiac Arrest

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.

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Key information

Conditions

Cardiac Arrest (CA) Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

37 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHOC, Orange, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPTI-VENT Bundle

Other

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.

Transition

Other

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.

None - control

Other

Control - no intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ventilation rate

    Time frame: Two minutes after CPR start through end of CPR

    Intra-arrest ventilation rate between 18 - 32 breaths per minute. Ventilation rate will be calculated as an event average, excluding the first two minutes of the event. Percentage of events achieving target in control vs. intervention will be compared.

Other outcomes

  1. Return of spontaneous circulation (ROSC) lasting >20 minutes

    Time frame: Duration of CPR event through 20 minutes after CPR

    Percentage of events achieving ROSC in control vs. intervention will be compared.

  2. Return of circulation (via ROSC or eCPR)

    Time frame: Duration of CPR event through 20 minutes after CPR

    Percentage of events achieving return of circulation in control vs. intervention will be compared.

  3. Survival to discharge

    Time frame: From cardiac arrest to hospital discharge, estimated average of 6-12 months

    Percentage of subjects surviving to discharge in control vs. intervention will be compared.

  4. Survival with no new morbidity (change in Functional Status Score (FSS) from baseline of < 3 points)

    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

    FSS is scored on a scale of 1-5 (lower number is better function) across 6 functional categories (mental status, sensory, communication, motor function, feeding, respiratory). Percentage of subjects surviving with no new morbidity in control vs. intervention will be compared.

  5. Intra-arrest cerebral oxygen saturation

    Time frame: Duration of CPR event

    Intra-arrest cerebral oxygen saturation as a continuous variable will be compared between intervention and control.

  6. Intra-arrest diastolic blood pressure (DBP)

    Time frame: Duration of CPR event

    Invasive arterial blood pressure (mmHg) as a continuous variable will be compared between intervention and control.

  7. Intra-Arrest Diastolic Blood Pressure (DBP) Target

    Time frame: Duration of CPR

    Percentage of patients achieving DBP targets (>25mmHg in infants < 1 year of age; >30mmHg in older children) will be compared between control vs. intervention.

  8. Hyperoxia (PaO2 >300 mmHg)

    Time frame: During the first 24 hours after return of circulation.

    Percentage of subjects in control vs. intervention will be compared.

  9. Hypocarbia (PaCO2 <30 mmHg)

    Time frame: During the first 24 hours after return of circulation.

    Percentage of subjects in control vs. intervention will be compared.

Study contacts

Contact information is provided by the study sponsor or research team.

CHOP RSC Clinical Research Program Manager

CONTACT

[email protected]

215-590-1859

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Utah
  • Villanova University

Registry information

Official study title

OPTImal Ventilation to Improve Pediatric Cardiac Arrest Outcomes (OPTI-VENT)

Acronym: OPTI-VENT

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 11, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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