Ventilation Strategies for Cardiac Arrest

(OPTIVO Trial)

ID
Overseen ByIan Drennan, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sunnybrook Health Sciences Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the delivery of ventilations (breaths given to a person who is not breathing) during CPR for cardiac arrest patients. Researchers are testing two different air volumes, High Volume Ventilation and Low Volume Ventilation, to determine which is more effective in supporting heart and lung function during emergencies. The focus is on adults experiencing heart-related cardiac arrest, treated by paramedics using a ventilation monitor. This study will help develop better guidelines for providing breaths during CPR. As an unphased trial, it offers participants the chance to contribute to vital research that could enhance emergency care practices.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that these ventilation strategies are safe for cardiac arrest patients?

A previous study linked using lower amounts of air during ventilation to better brain function and more ventilator-free days. This finding suggests that less air might ease the body's burden and aid recovery. Another study found that patients receiving less air had a lower risk of dying in the ICU compared to those receiving more air, indicating that less air could be a safer option.

However, current guidelines recommend using 500-600 milliliters of air during CPR, as this amount is believed to effectively fill the lungs. Research on the optimal way to provide air during CPR is still ongoing. Both lower and higher air volumes have shown some safety and effectiveness in past studies, but further research is needed to determine the best method.12345

Why are researchers excited about this trial?

Researchers are excited about the ventilation strategies being tested for cardiac arrest because they could significantly enhance how patients are supported during emergencies. Traditional ventilation methods often focus on standardized volumes, but this trial explores both high and low volume ventilation to see which might better support heart function and improve patient outcomes. By tailoring ventilation volumes more precisely, the goal is to optimize oxygen delivery and potentially reduce the risk of further complications. This trial could pave the way for more personalized and effective emergency care protocols, offering new hope for patients experiencing cardiac arrest.

What evidence suggests that this trial's ventilation strategies could be effective for cardiac arrest?

Research has shown that using smaller breaths during CPR for cardiac arrest can lead to better outcomes. In this trial, participants will receive either a low-volume or high-volume ventilation strategy. Studies have found that patients who received smaller breaths had better brain function and spent fewer days on a ventilator. Another study found that patients who received the right amount of air had a higher chance of survival. Smaller breaths also help improve oxygen levels and reduce lung pressure during CPR. This evidence suggests that smaller breaths could be more effective in treating cardiac arrest patients.13678

Who Is on the Research Team?

ID

Ian Drennan, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

SC

Sheldon Cheskes, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have had a cardiac arrest outside the hospital, are being treated by paramedics, and do not have a DNR order. It excludes those with traumatic or respiratory-related cardiac arrests, pregnant individuals, prisoners, or anyone without ventilation monitoring.

Inclusion Criteria

I am 18 years old or older.
My condition is believed to be caused by a heart problem.
Patients treated by paramedics
See 1 more

Exclusion Criteria

Presence of a Do Not Resuscitate (DNR) order
Absence of ventilation monitor usage
Traumatic cardiac arrest
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ventilation interventions during cardiac arrest with real-time feedback

1 hour
In-field intervention

Follow-up

Participants are monitored for survival to hospital admission and discharge

Up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

  • High Volume Ventilation
  • Low Volume Ventilation

Trial Overview

The study compares two ways of giving breaths during CPR—high volume versus low volume ventilation—to see which method improves survival after out-of-hospital cardiac arrest. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Low Volume (350ml (+/50ml)Experimental Treatment1 Intervention
Group II: 600ml (+/-50ml)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Zoll Medical Corporation

Industry Sponsor

Trials
48
Recruited
23,100+

Citations

Study finds poor ventilation use during CPR for out-of- ...

Patients in the group with the higher number of ventilations had better clinical outcomes, including a three times higher rate of survival-to- ...

Optimizing Ventilation to Improve Survival From Out-of- ...

Research examining passive oxygenation (no active ventilation) demonstrates mixed results with respect to cardiac arrest outcomes. While ...

Ventilatory parameters during emergency department– ...

This single-center prospective observational study described ventilation practices during ED-based CPR in adult patients with non-traumatic cardiac arrest who ...

Favorable Neurocognitive Outcome with Low Tidal Volume ...

Conclusions: Lower Vt after OHCA is independently associated with favorable neurocognitive outcome, more ventilator-free days, and more shock- ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28267376/

Favorable Neurocognitive Outcome with Low Tidal Volume ...

Lower Vt after OHCA is independently associated with favorable neurocognitive outcome, more ventilator-free days, and more shock-free days.

Low Frequency Ventilation During Cardiopulmonary ...

The use of LFV during CPB in patients undergoing valvular surgery was feasible and safe and was associated with changes in sRAGE levels along with better ...

Low-Tidal-Volume Ventilation and Mortality in Patients With ...

ARDS developed in 137 patients (9.2%). In patients receiving LTVV, adjusted incidence of ICU mortality was 40.2% (95% CI, 19.2%-61.1%), vs 59.7% ...

Study finds poor ventilation use during CPR for out

Ventilation with measurable lung inflation in ≥50% of pauses was associated with significantly increased rates of ROSC, survival, and increased ...