OPTI-VENT for Cardiac Arrest

(OPTI-VENT Trial)

Recruiting at 19 trial locations

Overseen By CHOP RSC Clinical Research Program Manager

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Brain death, Out-of-hospital arrest, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1530 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the OPTI-VENT Bundle to help children who have experienced cardiac arrest in the hospital. The aim is to determine if this approach can improve survival rates and neurological outcomes, which refers to brain function after recovery. Participants will receive either standard ICU care or the new OPTI-VENT treatment following a brief transition period. The trial seeks children who have undergone CPR for at least one minute and have had a breathing tube placed during or shortly after CPR. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance future care for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the OPTI-VENT Bundle is safe for pediatric cardiac arrest patients?

Research shows that the OPTI-VENT bundle is being tested to improve recovery for children after a heart attack. Although specific safety data is not available, the OPTI-VENT bundle focuses on teaching and guiding during CPR, including the use of a metronome app to maintain the correct breathing pace. This type of training is generally very safe, as it aims to enhance current methods rather than introduce new drugs or surgeries. The study is labeled as "Not Applicable" for trial phases, indicating that the approach is expected to be safe. However, due to the lack of detailed safety data, discussing any potential risks with the study team is important before deciding to join. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OPTI-VENT Bundle for cardiac arrest because it introduces new strategies to improve CPR ventilation rates, which are crucial during resuscitation. Unlike standard ICU practices, this approach includes brief educational sessions for providers and uses a metronome app to ensure precise ventilation timing. By integrating these elements, the OPTI-VENT Bundle aims to enhance the effectiveness of CPR, potentially improving patient outcomes during cardiac arrest.

What evidence suggests that the OPTI-VENT Bundle is effective for improving survival in pediatric cardiac arrest?

Studies have shown that the OPTI-VENT bundle, tested in this trial, might improve outcomes for children experiencing cardiac arrest. This bundle trains healthcare providers to use correct breathing rates during CPR, which are crucial for ensuring the brain and other vital organs receive enough oxygen. Early research suggests that using the right breathing rates can enhance survival chances and support healthier brain function after CPR. This approach could lead to more children surviving cardiac arrest with fewer long-term health problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert Sutton, MD, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for hospitalized children who have experienced cardiac arrest and are receiving at least one minute of CPR. The study aims to include those in need of improved survival rates with favorable neurological outcomes.

Inclusion Criteria

I have received CPR for at least 1 minute.

I had a breathing tube inserted at the start or within 5 minutes of CPR.

Exclusion Criteria

I was admitted to the hospital due to a cardiac arrest outside of a hospital.

I was on a heart-lung machine when CPR started.

Brain death determination prior to the CPR event

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Arm

Participants begin on the control arm with standard ICU resuscitation practices

2 months

Transition Period

A 2-month transition period as sites onboard to the OPTI-VENT Bundle intervention

2 months

OPTI-VENT Bundle Intervention

Implementation of the OPTI-VENT Bundle, including provider education and point-of-care guidance

Remainder of study period

Follow-up

Participants are monitored for survival to discharge and neurological outcomes

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• OPTI-VENT Bundle

Trial Overview The effectiveness of the OPTI-VENT bundle, which is a set of interventions designed to optimize ventilation during CPR, is being tested against standard care (control group) to see if it improves survival and brain function after cardiac arrest.

How Is the Trial Designed?

Group I: Site 9 Experimental Treatment 3 Interventions

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 II: Site 8 Experimental Treatment 3 Interventions

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 III: Site 7 Experimental Treatment 3 Interventions

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 IV: Site 6 Experimental Treatment 3 Interventions

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 V: Site 5 Experimental Treatment 3 Interventions

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 VI: Site 16 Experimental Treatment 3 Interventions

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 VII: Site 15 Experimental Treatment 3 Interventions

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 VIII: Site 14 Experimental Treatment 3 Interventions

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 IX: Site 13 Experimental Treatment 3 Interventions

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 X: Site 12 Experimental Treatment 3 Interventions

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 XI: Site 11 Experimental Treatment 3 Interventions

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 XII: Site 10 Experimental Treatment 3 Interventions

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 XIII: OPTI-VENT Bundle Experimental Treatment 1 Intervention

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 XIV: Control Experimental Treatment 1 Intervention

Standard ICU resuscitation practices throughout study

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Villanova University

Collaborator

Trials

8

Recruited

3,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07114510

Optimal Ventilation for Cardiac Arrest (OPTI-VENT) The objective of this study is to evaluate the effectiveness of the OPTI-VENT bundle to improve survival to discharge with favorable neurological outcome ( ...

2. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11047199

OPTImal VENTilation to Improve Pediatric Cardiac Arrest ... In Aim 1, we will execute a randomized trial to determine if training to the 2020 CPR ventilation rates with the OPTI-VENT bundle can improve patient outcomes.

3. research.chop.edu research.chop.edu/cornerstone-blog/researchers-breathe-new-life-into-cpr-to-improve-pediatric-cardiac-arrest-outcomes

Researchers Breathe New Life into CPR to Improve Pediatric ... The goal is to evaluate the effectiveness of the OPTImizing VENTilation (OPTI-VENT), a pediatric CPR ventilation rate training bundle, in ...

4. ctv.veeva.com ctv.veeva.com/study/optimal-ventilation-for-cardiac-arrest

Optimal Ventilation for Cardiac Arrest (OPTI-VENT) The objective of this study is to evaluate the effectiveness of the OPTI-VENT bundle to improve survival to discharge with favorable ...

5. withpower.com withpower.com/trial/phase-heart-arrest-8-2025-6d376

OPTI-VENT for Cardiac Arrest (OPTI-VENT Trial) The objective of this study is to evaluate the effectiveness of the OPTI-VENT bundle to improve survival to discharge with favorable neurological outcome ( ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000731?doi=10.1161/CIR.0000000000000731

2019 American Heart Association Focused Update on ... These studies found no statistical difference in positive outcomes or complications between TTM 32°C to 34°C and TTM 36°C to 37.5°C groups in ...