Optimal Ventilation for Cardiac Arrest

Not Applicable

Not yet recruiting

• Conditions: Cardiac Arrest (CA)

• Registration Number: NCT07114510
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-09-01
• Primary Completion: 2030-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1530

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival with a favorable neurologic outcome	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 Outcome Measures

Name	Time	Method
Ventilation rate	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.

Trial Locations

Locations (20)

CHOC; 🇺🇸 Orange, California, United States

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States

Children's Hospital Colorado; 🇺🇸 Denver, Colorado, United States

Nemours Children's Health; 🇺🇸 Wilmington, Delaware, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Riley Children's Health; 🇺🇸 Indianapolis, Indiana, United States

Stead Family Children's Hospital; 🇺🇸 Iowa City, Iowa, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Cohen Children's Medical Center; 🇺🇸 New Hyde Park, New York, United States

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