Optimizing Ventilation to Improve Survival From Out-of-hospital Cardiac Arrest: the OPTIVO Randomized Controlled Trial

NCT07479836 | Not Yet Recruiting DMC

• 1 other identifier: 5783
• Study Type: interventional
• Target: 1,656
• Locations: 1 country
• Sites: 1

Brief Summary

When the heart stops pumping during cardiac arrest, cardiopulmonary resuscitation (CPR) is used to continue pushing blood and providing oxygen to vital organs. CPR involves a combination of chest compressions (to push the blood) and ventilations (to provide oxygen and gas exchange). There is a lot of research that has helped to optimize the provision of chest compressions, however there is considerably less research available to guide ventilations. The current guideline recommendations are based on limited data, and no data that is specific to cardiac arrest patients. There is a recognized need for research to better guide ventilation during CPR. This research will help to better define appropriate ventilation targets for cardiac arrest patients.

Conditions

Cardiac Arrest

Keywords

Resuscitation; Ventilation; Cardiopulmonary Resuscitation; Out-of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Return of Spontaneous Circulation

  At any time in the prehospital setting as documented by paramedics

  Prior to arrival at the hospital. This will occur within 1 hr after enrolment in most patients.

Secondary Outcomes (2)

• Survival to Hospital Discharge

  Discharge from hospital is likely to occur within 30 days of the cardiac arrest event for most patients.

• Survival to Hospital Admission

  Hospital Admission - estimated to occur within 6 hrs of arrival at hospital for most patients.

Study Arms (2)

Low Volume (350ml (+/50ml)

EXPERIMENTAL

Other: Low Volume Ventilation

600ml (+/-50ml)

ACTIVE COMPARATOR

Other: High Volume Ventilation

Interventions

Low Volume Ventilation OTHER

Patients in cardiac arrest will be ventilated with a volume of 350ml (+/- 50 ml)

Low Volume (350ml (+/50ml)

High Volume Ventilation OTHER

600ml (+/-50ml)

600ml (+/-50ml)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>=18 years of age)
• presumed cardiac etiology
• treated by paramedics
• Ventilation monitor utilized

You may not qualify if:

• Do Not Resuscitate (DNR) order
• No use of ventilation monitor
• Traumatic cardiac arrest
• Pregnant patients
• Prisoners
• Respiratory cause of cardiac arrest (e.g. drowning, hanging, suffocation, opioid-related)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Zoll Medical Corporation: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Heart Arrest; Respiratory Aspiration; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Drennan, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Sheldon Cheskes, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Drennan, PhD

CONTACT

416-667-2200; ian.drennan@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Scientist

Model Details: Cluster Crossover Clinical Trial

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CA (1)