Optimal Ventilation for Cardiac Arrest

NCT ID: NCT07114510

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2030-03-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

Standard ICU resuscitation practices throughout study

Group Type: EXPERIMENTAL

None - control

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no intervention

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.

Group Type: EXPERIMENTAL

OPTI-VENT Bundle

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Control - no 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.

Intervention Type: 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.

Intervention Type: OTHER

None - control

Control - no intervention

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 37 Weeks
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

Villanova University

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Sutton, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

CHOC

Orange, California, United States

Site Status: RECRUITING

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Site Status: RECRUITING

Children's Hospital Colorado

Denver, Colorado, United States

Site Status: RECRUITING

Nemours Children's Health

Wilmington, Delaware, United States

Site Status: RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Riley Children's Health

Indianapolis, Indiana, United States

Site Status: RECRUITING

Stead Family Children's Hospital

Iowa City, Iowa, United States

Site Status: RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Washington University in St. Louis

St Louis, Missouri, United States

Site Status: RECRUITING

Cohen Children's Medical Center

New Hyde Park, New York, United States

Site Status: RECRUITING

UNC Children's Hospital

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Dell Children's Medical Center

Austin, Texas, United States

Site Status: RECRUITING

Medical City Children's Hospital

Dallas, Texas, United States

Site Status: RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Site Status: RECRUITING

Seattle Children's

Seattle, Washington, United States

Site Status: RECRUITING

Children's Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

CHOP RSC Clinical Research Program Manager

Role: CONTACT

grahamk1@chop.edu

215-590-1859

Facility Contacts

Jennifer Hayes

Role: primary

jhayes@choc.org

909-614-3592

Azadeh Fayazi

Role: primary

afayazi@stanford.edu

650-721-4320

Lorel Huber

Role: primary

lorel.huber@childrenscolorado.org

314-805-7058

Yosef Levenbrown

Role: primary

Yosef.Levenbrown@nemours.org

201-390-4961

Stephanie Brown

Role: primary

stephanie.rachelle.brown@emory.edu

216-333-3806

Maria Frazier

Role: primary

mfrazier7@iuhealth.org

937-272-5832

Sarah Haskell

Role: primary

sarah-haskell@uiowa.edu

319-353-6464

Catherine Ross

Role: primary

Catherine.Ross@childrens.harvard.edu

785-766-7214

Stu Friess

Role: primary

friess@wustl.edu

314-286-2799

Todd Sweberg

Role: primary

Tsweberg@northwell.edu

718-470-3668

Afsaneh Pirzadeh

Role: primary

afsaneh_pirzadeh@med.unc.edu

919-889-3888

Daniel Loeb

Role: primary

Daniel.Loeb@cchmc.org

216-299-0004

John Jennings

Role: primary

john.jennings@nationwidechildrens.org

614-722-4619

Amanda O'Halloran

Role: primary

ohallorana@chop.edu

508-692-7502

Hunter Daigle

Role: primary

hunter.daigle@utexas.edu

512-550-7786

Tia Raymond

Role: primary

tia.raymond@hcahealthcare.com

972-533-7175

Priscilla Yu

Role: primary

Priscilla.Yu@UTSouthwestern.edu

241-456-1269

Michelle Olson

Role: primary

michelle.olson@vcuhealth.org

804-628-5488

Joan Roberts

Role: primary

joan.roberts@seattlechildrens.org

206-987-5119

Andrea Maxwell

Role: primary

amaxwell@mcw.edu

712-870-1959

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Provided Documents

Document Type: Study Protocol

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Other Identifiers

1R01HD114622-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-022623

Identifier Type: -

Identifier Source: org_study_id