Recruiting

OPTI-VENT Bundle

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07114510

Conditions

Cardiac Arrest (CA)

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

OPTI-VENT Bundle

Transition

None - control

Study Details

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.

Conditions

Cardiac Arrest (CA)

Study ID

NCT07114510

Start date

Oct 1, 2025

Status verified date

Oct, 2025

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Enrollment

1530 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Control

Standard ICU resuscitation practices throughout study

experimental: 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.

experimental: Site 5

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 6

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 7

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 8

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 9

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 10

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 11

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 12

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 13

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 14

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 15

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

experimental: Site 16

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Interventions

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.

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.

None - control

Control - no intervention

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

CHOP RSC Clinical Research Program Manager

215-590-1859grahamk1@chop.edu

Locations

CHOC

Recruiting

Orange, California, United States, 92868

Contacts

Jennifer Hayes

909-614-3592jhayes@choc.org

Lucile Packard Children's Hospital Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Azadeh Fayazi

650-721-4320afayazi@stanford.edu

Children's Hospital Colorado

Recruiting

Denver, Colorado, United States, 80045

Contacts

Lorel Huber

314-805-7058lorel.huber@childrenscolorado.org

Nemours Children's Health

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Yosef Levenbrown

201-390-4961Yosef.Levenbrown@nemours.org

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Stephanie Brown

216-333-3806stephanie.rachelle.brown@emory.edu

Riley Children's Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Maria Frazier

937-272-5832mfrazier7@iuhealth.org

Stead Family Children's Hospital

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Sarah Haskell

319-353-6464sarah-haskell@uiowa.edu

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Catherine Ross

785-766-7214Catherine.Ross@childrens.harvard.edu

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Stu Friess

314-286-2799friess@wustl.edu

Cohen Children's Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Todd Sweberg

718-470-3668Tsweberg@northwell.edu

UNC Children's Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Afsaneh Pirzadeh

919-889-3888afsaneh_pirzadeh@med.unc.edu

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Daniel Loeb

216-299-0004Daniel.Loeb@cchmc.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

John Jennings

614-722-4619john.jennings@nationwidechildrens.org

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Amanda O'Halloran

508-692-7502ohallorana@chop.edu

Dell Children's Medical Center

Recruiting

Austin, Texas, United States, 78723

Contacts

Hunter Daigle

512-550-7786hunter.daigle@utexas.edu

Medical City Children's Hospital

Recruiting

Dallas, Texas, United States, 75230

Contacts

Tia Raymond

972-533-7175tia.raymond@hcahealthcare.com

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Priscilla Yu

241-456-1269Priscilla.Yu@UTSouthwestern.edu

Children's Hospital of Richmond at VCU

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Michelle Olson

804-628-5488michelle.olson@vcuhealth.org

Seattle Children's

Recruiting

Seattle, Washington, United States, 98105

Contacts

Joan Roberts

206-987-5119joan.roberts@seattlechildrens.org

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Andrea Maxwell

712-870-1959amaxwell@mcw.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Keywords

  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2025-10-08.