High Flow Oxygen vs Noninvasive Ventilation for Acute Respiratory Failure

(HIFOLD2 Trial)

Overseen By Nattapat Wongtirawit, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Clinical instability, Intubation need, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

NIV is a life-saving treatment for people with breathing failure and carbon dioxide (CO2) retention. It helps remove this waste gas from the lungs and reduces the effort needed to breathe. However, the standard masks used for NIV can become uncomfortable over time, which may lead patients to stop using them. Stopping treatment can be dangerous and may cause breathing problems to worsen. That's why finding devices that are more comfortable and possibly more effective is very important. This study aims to take a first step in that direction.

This is the first study comparing new devices designed to help people with chronic CO2 buildup during breathing flare-ups. Devices tested include a new type of asymmetrical nasal cannula for high-flow oxygen therapy and a new mask called OptiNIV, which has a comfortable design that may help remove more CO2.

These devices will be compared to standard NIV masks currently used in hospitals. Outcome of interests include their effects on the effort needed to breathe, on how much CO2 is cleared, and on how comfortable they are.

Are You a Good Fit for This Trial?

This trial is for people with acute respiratory failure who have trouble breathing and high levels of CO2 in their blood. Participants should be experiencing a flare-up of chronic respiratory issues but specifics on inclusion or exclusion criteria are not provided.

Inclusion Criteria

I have been diagnosed with a severe increase in CO2 in my blood.

I am currently in the intensive care unit.

I am currently receiving high-flow oxygen or non-invasive ventilation.

Exclusion Criteria

Requiring immediate need of endotracheal intubation, according to the judgement of the attending physician

Contraindications of monitoring with electrical impedance tomography (e.g. pacemaker, chest wall burns wounds limiting electrode placement)

I do not have severe breathing problems, very low oxygen levels, a lung leak, extremely low consciousness, or dangerously low blood pressure despite medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive sequential respiratory support with 3 devices, including a new type of asymmetrical nasal cannula for high-flow oxygen therapy and a new mask called OptiNIV

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on power of breathing, ventilatory ratio, patient's comfort, and subjective shortness of breath

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Asymmetrical High Flow Oxygen
• Noninvasive Ventilation

Trial Overview The study compares three devices: a new asymmetrical nasal cannula, a novel mask called OptiNIV, and standard non-invasive ventilation (NIV) masks. It will assess how well they help patients breathe, clear CO2, and their comfort level during use.

How Is the Trial Designed?

Group I: All study patient Experimental Treatment 3 Interventions

Sequential respiratory support with 3 devices

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+