HFNO With or Without Helmet NIV for Hypoxemic Respiratory Failure

(HONOUR Trial)

Recruiting at 10 trial locations

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Neuromuscular disease, Palliative care, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to assist people with Acute Hypoxemic Respiratory Failure, a severe breathing difficulty. It compares two methods: helmet non-invasive ventilation (a special helmet that aids breathing) combined with high-flow nasal oxygen, versus high-flow nasal oxygen alone. Individuals in an intensive care unit with breathing issues that began within the last two weeks, and who are not already using certain breathing aids, might find this trial suitable.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

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

The trial protocol 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that helmet non-invasive ventilation (HNIV) offers a promising method for assisting individuals with severe breathing problems. In one study involving adults with serious respiratory issues, those using the helmet experienced positive outcomes. The study reported no major safety concerns, indicating it as a well-tolerated option.

For high flow nasal oxygen (HFNO), studies have shown it to be a safe and effective treatment for individuals with low oxygen levels. It improves breathing and is recommended to avoid more invasive procedures, such as intubation. Safety data indicates that HFNO is very well-tolerated, with no serious side effects commonly reported.

Overall, both HNIV and HFNO have demonstrated safety for individuals with breathing problems. They are widely used and accepted treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for hypoxemic respiratory failure because they explore innovative ways to deliver oxygen to patients. Unlike the standard of care that typically involves invasive mechanical ventilation, Helmet Non-Invasive Ventilation (H-NIV) offers a non-invasive approach, providing a helmet-like device that ensures a steady flow of oxygen while allowing patients more comfort and freedom. Meanwhile, High Flow Nasal Oxygen (HFNO) delivers oxygen through nasal cannulas at a high flow rate, which can improve oxygenation without the need for invasive procedures. These methods could potentially reduce complications and improve patient outcomes by offering less invasive options with similar or even enhanced effectiveness.

What evidence suggests that this trial's treatments could be effective for Acute Hypoxemic Respiratory Failure?

Research has shown that high flow nasal oxygen (HFNO), a treatment in this trial, is effective for sudden breathing problems due to low oxygen levels. Studies have found that HFNO can reduce the need for a breathing tube. It is often recommended because it helps patients breathe better without additional equipment.

Helmet non-invasive ventilation (HNIV) is another treatment option under study in this trial. Some studies suggest it could lower the need for intubation compared to a face mask. However, the evidence remains less certain, and it has not clearly demonstrated a reduction in death rates. Both treatments aim to help patients breathe easier and avoid more invasive procedures. ^{2 3 4 6 7}

Who Is on the Research Team?

Damon Scales, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Niall Fergusson, MD FRCPC

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults in the ICU with low oxygen levels despite receiving a moderate amount of oxygen, who have been experiencing acute respiratory failure for at least an hour. It's not suitable for those with neuromuscular diseases, recent trauma preventing helmet use, or conditions that make positive pressure to the face risky. Patients already on high-flow oxygen or needing immediate intubation are excluded.

Inclusion Criteria

Intensive care unit admission (orders written)

Your blood oxygen level is lower than 98% when you are using a high level of oxygen support.

If there is no test for the amount of oxygen and carbon dioxide in your blood, then the ratio of oxygen in your blood to the amount of oxygen you are breathing is less than 315.

Exclusion Criteria

ICU discharge is planned or anticipated on the day of screening

Previously enrolled in this trial

You have a known neuromuscular disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either helmet NIV with HFNO or HFNO alone for at least 2 days

2 days

Daily sessions in ICU

Follow-up

Participants are monitored until hospital discharge or up to 60 days, with a quality of life assessment at 6 months

60 days

In-hospital monitoring, 1 telephone interview at 6 months

Long-term follow-up

Assessment of mortality and quality of life up to 180 days

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Helmet Non-Invasive Ventilation (HNIV)
• High Flow Nasal Oxygen

Trial Overview

The study compares two ways to help patients breathe: one group will receive high flow nasal oxygen (HFNO) alone, and another will get HFNO combined with a special helmet that supports breathing without needing a tube in the windpipe. Participants are randomly assigned to either method.

How Is the Trial Designed?

Group I: H-NIV Active Control 1 Intervention

Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions

Group II: HFNO Active Control 1 Intervention

High Flow Nasal Oxygen alone

Helmet Non-Invasive Ventilation (HNIV) is already approved in European Union, United States for the following indications:

Approved in European Union as Helmet NIV for:

• Acute Hypoxemic Respiratory Failure
• Acute Respiratory Failure

Approved in United States as Helmet NIV for:

• Acute Hypoxemic Respiratory Failure
• COVID-19 related respiratory failure

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

In a study of 27 elderly patients with acute hypercapnic cardiogenic pulmonary edema, high-flow nasal cannula (HFNC) treatment for 1 hour significantly improved carbon dioxide levels and respiratory parameters, showing comparable efficacy to noninvasive ventilation (NIV).

Both HFNC and NIV led to improvements in pH, breathing frequency, and signs of work of breathing, suggesting that HFNC could be a viable alternative to NIV for early management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula in Early Emergency Department Management of Acute Hypercapnic Respiratory Failure Due to Cardiogenic Pulmonary Edema. Marjanovic, N., Flacher, A., Drouet, L., et al.[2021]

In a study involving 15 patients with acute hypoxemic respiratory failure, helmet noninvasive ventilation (NIV) significantly improved oxygenation (PaO2/FiO2) compared to high-flow nasal cannula (HFNC), with a median increase from 138 mm Hg to 255 mm Hg.

Helmet NIV also reduced inspiratory effort and dyspnea, leading to better patient comfort, while maintaining stable levels of carbon dioxide (PaCO2) and similar transpulmonary pressure swings compared to HFNC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure. Grieco, DL., Menga, LS., Raggi, V., et al.[2020]

Helmet noninvasive ventilation (NIV) may reduce the need for endotracheal intubation and decrease the duration of mechanical ventilation in patients with severe acute hypoxic respiratory failure (AHRF), based on six randomized controlled trials.

Current evidence on helmet NIV's impact on patient survival is inconsistent, highlighting the need for further studies to better understand its effectiveness compared to standard NIV methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helmet noninvasive ventilation in acute hypoxic respiratory failure. Buell, KG., Patel, BK.[2023]

This study is a multicentre, randomized controlled trial involving 320 patients, aiming to determine if non-invasive ventilation (NIV) delivered by helmet can reduce 28-day mortality in patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia compared to usual care alone.

The trial will assess both safety and effectiveness, with results expected to provide valuable insights into the potential benefits of helmet NIV in improving patient outcomes during respiratory failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial. Arabi, YM., Tlayjeh, H., Aldekhyl, S., et al.[2021]

In a review of 13 studies involving 1,956 immunocompromised patients, high-flow nasal cannula (HFNC) therapy was associated with a 28% reduction in mortality compared to conventional oxygen therapies and noninvasive ventilation, suggesting it may be a safer option for these patients.

HFNC also resulted in a lower rate of invasive mechanical ventilation (19% reduction) compared to other oxygen therapies, indicating its potential efficacy in managing acute hypoxemic respiratory failure in immunocompromised individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of High-Flow Nasal Oxygen in the Immunocompromised Critically Ill: A Systematic Review and Meta-Analysis. Sklar, MC., Mohammed, A., Orchanian-Cheff, A., et al.[2019]

In a study of 80 patients with COVID-19 hypoxemic respiratory failure, those treated with helmet noninvasive ventilation (NIV) showed similar long-term outcomes in quality of life and physical performance compared to those receiving high-flow nasal oxygen after 6 months.

Helmet NIV was associated with significantly lower rates of arthralgia (joint pain) compared to high-flow oxygen (16% vs. 55%), suggesting it may be a safer option for managing hypoxemic patients without compromising overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial. Michi, T., Mattana, C., Menga, LS., et al.[2023]

In a study of 28 patients with acute hypoxemic respiratory failure (AHRF), humidified oxygen via high-flow nasal cannula (HFNC) significantly improved oxygen levels (PaO2) and reduced breathing frequency compared to standard oxygen therapy.

HFNC was better tolerated than noninvasive ventilation (NIV), allowing patients to receive it for longer periods, and may serve as an effective strategy to maintain oxygenation between NIV sessions, especially in patients with ARDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential application of oxygen therapy via high-flow nasal cannula and noninvasive ventilation in acute respiratory failure: an observational pilot study. Frat, JP., Brugiere, B., Ragot, S., et al.[2022]

Non-invasive mechanical ventilation (NIV) using a helmet may be a safer and more tolerable alternative to face masks for patients with acute respiratory failure, as indicated by better tolerance in six studies and lower intubation rates in three studies.

While NIV with a helmet showed similar oxygenation levels compared to face masks, it also presented potential issues such as CO₂ rebreathing and increased ventilator asynchrony, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review: Helmet and non-invasive mechanical ventilation in critically ill patients. Esquinas Rodriguez, AM., Papadakos, PJ., Carron, M., et al.[2021]

Helmet noninvasive ventilation (NIV) may significantly reduce mortality and the need for intubation compared to facemask NIV in patients with acute respiratory failure, based on a systematic review of 16 RCTs involving 949 participants.

The evidence regarding helmet NIV's effectiveness compared to high-flow nasal cannula (HFNC) is uncertain, indicating that while it shows promise, further research is needed to clarify its role in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helmet noninvasive ventilation compared to facemask noninvasive ventilation and high-flow nasal cannula in acute respiratory failure: a systematic review and meta-analysis. Chaudhuri, D., Jinah, R., Burns, KEA., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9490511/

Effect of Helmet Noninvasive Ventilation vs Usual Respiratory ...

Helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic ...

2.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2796380

Effect of Helmet Noninvasive Ventilation vs Usual ...

Helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667100X25000040

Noninvasive ventilation in acute hypoxemic respiratory failure

A meta-analysis suggested that the helmet may reduce mortality and intubation rates compared to facemask NIV but these results were based on low certainty of ...

4.

annalsofintensivecare.springeropen.com

annalsofintensivecare.springeropen.com/articles/10.1186/s13613-022-01069-7

Helmet noninvasive support for acute hypoxemic respiratory ...

However, helmet NIV was associated with a reduction in the rate of endotracheal intubation in comparison with high-flow nasal oxygen (30% vs. 51 ...

5.

jintensivecare.biomedcentral.com

jintensivecare.biomedcentral.com/articles/10.1186/s40560-023-00669-0

Long-term outcome of COVID-19 patients treated with helmet ...

In patients with COVID-19 hypoxemic respiratory failure, treatment with helmet NIV or high-flow oxygen yielded similar quality of life and functional outcome ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9830589/

Helmet Non-Invasive Ventilation in Acute Hypoxic ...

In the Large Observational Study to understand the Global Impact of Severe Acute Respiratory Failure (LUNG SAFE), 15% of ARDS patients were treated with NIV.

7.

ccforum.biomedcentral.com

ccforum.biomedcentral.com/articles/10.1186/s13054-025-05369-9

Monitoring patients with acute respiratory failure during non ...

An increase in PaCO2 within the first days of NIV was independently associated with NIV failure in ARDS, probably indicating deterioration of ...