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New study tests helmet breathing aid for severe lung failure

NCT ID NCT05078034

Knowledge-focused Sponsor: Sunnybrook Health Sciences Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two ways to help people in the ICU who have trouble breathing due to low oxygen levels. It compares using a helmet-like device plus high-flow oxygen through the nose versus high-flow oxygen alone. The goal is to see which approach works better and to gather information for future larger studies. About 200 adults will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Intensive care unit admission (orders written) 2. Age ≥18 years 3. Hypoxemic acute respiratory failure for at least 1 hour and still present at time of screening for eligibility (symptom onset during last 14 days) with the following: 1. Respiratory rate \>21bpm or clinical evidence of increased work of breathing and 2. Documented Hypoxemia defined as any one of: i. PaO2:FiO2 \< 300 ii. If no arterial blood gas available, then SpO2:FiO2 \< 315 iii. Oxygen saturation \<98% on FiO2 \>= 0.4 or higher by Venturi mask, TAVISH mask 10 Litres / minute, or any non-invasive oxygenation strategy 4. Not already intubated or with tracheostomy Exclusion Criteria: 1. Already on HFNO or other non-invasive ventilation strategy at FiO2\>=0.4 for the last 24 hours in the ICU. 2. Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc) 3. Extubated in the ICU within past 72 hours 4. Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure 5. Known neuromuscular disease 6. Patients being transitioned to Palliative care or unlikely to survive more than 24 hours 7. ICU discharge is planned or anticipated on the day of screening 8. Previously enrolled in this trial 9. Trauma patients who remain in a cervical spine collar at the time of recruitment or who have upper limb/torso fractures that would preclude them from safe application of the helmet 10. Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. Transphenoidal surgery, basal skull fracture etc.)

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Conditions

The condition(s) this trial relates to.

acute respiratory failure respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute hypoxemic respiratory failure

Contacts and locations

Locations

  • Hamilton Health Sciences- Juravinski

    Hamilton, Ontario, Canada

  • Kingston General Hospital

    Kingston, Ontario, Canada

  • London Health Sciences Centre

    London, Ontario, Canada

  • Mount Sinai Hospital

    Toronto, Ontario, Canada

  • North York General Hospital

    Toronto, Ontario, M2K 1E1, Canada

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • University Health Network Toronto General

    Toronto, Ontario, Canada

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Calgary

    Calgary, Alberta, T2N 4N1, Canada

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