Helmet vs Facemask Ventilation for Acute Respiratory Failure

(HELMET Trial)

Overseen By Dipayan Chaudhuri, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Hamilton Health Sciences Corporation

Disqualifiers: Cardiac arrest, Coma, Airway obstruction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of non-invasive ventilation (NIV) for people with sudden breathing problems. Researchers aim to determine if a helmet is more effective than the traditional face mask in reducing deaths among these patients. The trial is open to adults in the ICU who require NIV due to sudden respiratory failure. As an unphased trial, it offers patients the chance to contribute to important research that could enhance future treatments for respiratory failure.

Will I have to stop taking my current medications?

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

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

Research shows that using a helmet for non-invasive ventilation (NIV) is generally comfortable for patients. Some studies suggest it might be as effective as, or even better than, a face mask for aiding breathing. For instance, one study found that using a helmet did not significantly change death rates compared to regular breathing support. Another study examined how helmets might reduce complications in patients with sudden breathing problems. Both helmet and face mask methods demonstrated similar safety and effectiveness.

In summary, both helmet and face mask NIV methods are considered safe. Past research has not reported any major safety concerns for either method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these ventilation methods for acute respiratory failure because they offer different interfaces for delivering non-invasive ventilation. The helmet ventilation system is unique as it completely encloses the patient's head, providing a sealed environment that might improve comfort and reduce air leaks compared to traditional facemasks. This could potentially enhance the effectiveness of ventilation and reduce the need for invasive procedures like intubation. These novel approaches aim to improve patient outcomes and experiences by exploring alternative delivery methods in critical respiratory care.

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

This trial will compare the effectiveness of Helmet NIV with Facemask NIV for patients with acute respiratory failure. Research suggests that using a helmet for noninvasive ventilation (NIV) might be more effective than a traditional face mask for patients with severe breathing problems. One study found that helmet NIV lowered the risk of death by 44% compared to face mask NIV. Another study showed that helmet NIV might reduce the need for intubation, which involves inserting a tube into a patient's airway to assist breathing. However, some studies did not find a significant difference in death rates between helmet NIV and other breathing support methods. Overall, helmet NIV appears promising, but results vary, and more research is needed for clearer answers. ^{1 3 6 7 8}

Who Is on the Research Team?

Bram Rochwerg, MD

Principal Investigator

Hamilton Health Science

Are You a Good Fit for This Trial?

This trial is for adults in the ICU who need non-invasive ventilation (NIV) due to sudden respiratory failure. It's not for those who use NIV regularly, have severe consciousness impairment (Glasgow coma scale <9), airway issues, are at risk of cardiac arrest or refuse intubation, have facial trauma, can't wear the equipment properly, or have certain untreated conditions like high brain pressure or pneumothorax.

Inclusion Criteria

You are currently staying in the adult intensive care unit.

My doctors say I need a breathing machine for my lung failure.

Exclusion Criteria

I have high pressure inside my skull.

Your Glasgow Coma Scale score is less than 9.

I have experienced facial trauma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive ventilation through either a helmet or facemask for up to 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ICU and hospital mortality and length of stay

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Facemask NIV
• Helmet NIV

Trial Overview The study is testing if a new type of NIV called 'helmet' is better than the traditional face mask in helping patients with acute respiratory failure and preventing death. The goal is to see if it's feasible to do a larger study on this topic.

How Is the Trial Designed?

Group I: Helmet NIV Experimental Treatment 1 Intervention

Patients randomized to the intervention arm will receive NIV through a phthalate free helmet (CaStar, STARMED) via an ICU ventilator in pressure support (PS) mode.

Group II: Facemask NIV Active Control 1 Intervention

Patients in the control arm will be randomized to the traditional facemask interface. The facemask group will use the same ICU ventilator being used for the helmet group.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4967560/

Effect of Noninvasive Ventilation Delivered by Helmet vs ... A study by Frat et al showed increased mortality was associated with face mask NIV for AHRF compared with high-flow nasal cannula. About half of patients with ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10636453/

Safety and efficacy of noninvasive ventilation for acute ... The primary outcome demonstrated that the rate of NIV failure at 48 hours was 20.9%, and the secondary outcomes showed in-hospital mortality of 12.8%. In ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04507802

Helmet vs Face Mask in Patients With Acute Respiratory ... The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates.

5. publications.ersnet.org publications.ersnet.org/content/erj/59/3/2101269

Helmet noninvasive ventilation compared to facemask ... Compared to facemask NIV, based on low certainty of evidence, helmet NIV may reduce mortality (relative risk 0.56, 95% CI 0.33–0.95) and intubation (relative ...

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

Effect of Helmet Noninvasive Ventilation vs Usual ... Results of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among ...

7. nature.com nature.com/articles/s41598-020-78607-5

Noninvasive ventilation with a helmet in patients with acute ... We evaluated whether NIV with helmet decreases the incidence of complications and improves its effects in a single center. Patients with ARF ...

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

Monitoring patients with acute respiratory failure during non ... Recent data suggest that helmet might be superior or at least equally effective to facemask CPAP/NIV [26–28]. Furthermore, HFNO can also be ...