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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new devices for people with breathing problems due to a buildup of carbon dioxide (CO2). It compares a new nasal cannula for high-flow oxygen (asymmetrical high-flow oxygen) and a comfortable mask called OptiNIV to the standard masks used in hospitals. The goal is to determine which option eases breathing, clears CO2 better, and provides more comfort for patients. Individuals admitted to the ICU with breathing failure and receiving high-flow oxygen or non-invasive ventilation may be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future respiratory care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these devices are safe for treating acute respiratory failure?

Research has shown that asymmetrical high-flow oxygen therapy is generally safe and can help people with breathing problems breathe more easily. Studies have found it slightly improves comfort and reduces the effort needed to breathe without affecting lung function. However, it might delay necessary treatments like intubation if not monitored closely.

Noninvasive ventilation (NIV) is another safe option for people with breathing issues. Research indicates that while some patients may not respond to NIV and need more help, it often reduces the need for intubation and lowers death rates in hospitals. Although some patients, especially those with severe conditions, may not benefit from NIV, most people tolerate the treatment well.

Both treatments are considered safe in many cases, but like any medical treatment, they come with some risks and may not work for everyone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using asymmetrical high flow oxygen and noninvasive ventilation for acute respiratory failure because these methods offer a more flexible and potentially more comfortable approach compared to traditional mechanical ventilation. Unlike standard treatments that can be invasive and uncomfortable, high flow oxygen delivers oxygen through a simple nasal cannula, which may enhance patient comfort and compliance. Noninvasive ventilation, on the other hand, provides respiratory support through a mask, reducing the need for intubation and associated complications. Together, these methods could provide effective support while minimizing patient discomfort and the risks linked with invasive procedures.

What evidence suggests that this trial's devices could be effective for acute respiratory failure?

This trial will compare Asymmetrical High Flow Oxygen with Noninvasive Ventilation (NIV) for treating acute respiratory failure. Studies have shown that NIV can ease breathing and reduce the need for a breathing tube, and it has been linked to lower death rates in patients with severe breathing issues, particularly those caused by pneumonia. In contrast, Asymmetrical High Flow Oxygen, a device for delivering oxygen, can also ease breathing and may offer more comfort for patients. Research suggests it might reduce risks like pneumonia more effectively than NIV while aiding in breathing. Both treatments aim to ease breathing, but their comfort and effectiveness can vary depending on the patient's condition. ^{2 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775427/

Asymmetrical high-flow nasal cannula performs similarly to ... According to the last European Respiratory Society task force, HFNC is a valuable intervention for improving lung aeration, oxygenation and ...

2. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04441-6

Effects of an asymmetrical high flow nasal cannula interface in ... An asymmetrical HFNC interface reduces minute ventilation and work of breathing in patients with mild-to-moderate hypoxemic respiratory failure ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07157098

Study Details | NCT07157098 | Asymmetrical High Flow ... Outcome of interests include their effects on the effort needed to breathe, on how much CO2 is cleared, and on how comfortable they are.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1503326

High-Flow Oxygen through Nasal Cannula in Acute ... The physiological effects of noninvasive ventilation include a decrease in the work of breathing and improvement in gas exchange. In patients ...

5. acpjournals.org acpjournals.org/doi/10.7326/M20-4675

Effectiveness and Harms of High-Flow Nasal Oxygen for ... Compared with NIV, HFNO may reduce all-cause mortality, intubation, and hospital-acquired pneumonia and improve patient comfort in initial ARF management.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10111067/

Effects of an asymmetrical high flow nasal cannula ... An asymmetrical HFNC interface reduces minute ventilation and work of breathing in patients with mild-to-moderate hypoxemic respiratory failure supported with ...

7. thoracrespract.org thoracrespract.org/articles/a-novel-approach-to-high-flow-nasal-oxygen-delivery-physiological-and-clinical-perspectives-on-asymmetrical-cannulas/doi/ThoracResPract.2025.2025-3-2

A Novel Approach to High-flow Nasal Oxygen Delivery Failure of the HFNC may result in admission to the intensive care unit (ICU).21 The major concern is that the use of HFNC may delay necessary intubation and ...

8. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02820-x

Asymmetrical high-flow nasal cannula performs similarly to ... The use of the asymmetrical HFNC, as compared to standard HFNC interface, slightly improved patient comfort without affecting lung aeration, diaphragm activity.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2667100X24001397

High-flow nasal oxygen is the reference treatment in acute ... HFNO has emerged as the reference treatment and is recommended for patients with hypoxemic ARF given its benefit in reducing the risk of intubation.