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ER study to determine best breathing aid for oxygen crisis

NCT ID NCT07558265

Knowledge-focused Sponsor: Ohio State University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will compare two non-invasive breathing support methods—a face mask that pushes air in and a special nasal tube that delivers high-flow oxygen—for adults in the emergency room with dangerously low blood oxygen. About 500 participants will be randomly assigned to one method, and researchers will track survival, days on a breathing machine, and how long support is needed. The goal is to find which approach works best as a first treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors choose the best initial breathing support for emergency patients with low oxygen levels, potentially improving survival and reducing time on a ventilator.
What could go wrong
This is an early-stage comparison study, not testing a new drug or cure. Results may not apply to all patients, and individual responses to the devices can vary.

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 500 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

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: * Age ≥18 years * Presenting to the Emergency Department (ED) with Acute Hypoxemic Respiratory failure (AHRF), defined as: * \[(respiratory rate ≥25 breaths/min) AND (requiring ≥6 L/min of oxygen required to maintain SpO2 ≥90%), OR SpO2:FiO2 ratio\<250\] OR * Arrival at ED on prehospital Non-Invasive Respiratory Support (NIRS). * Clinical need for NIRS * Randomization ≤2 hours after identification of need for NIRS * Randomization ≤6 hours of ED arrival Exclusion Criteria: * Urgent need for intubation * Cardiac arrest * Respiratory arrest * Patient not located in the ED * Craniofacial anatomic features that prohibit either Non-Invasive Positive Pressure Ventilation (NIPPV) or High Flow Nasal Oxygen (HFNO) interface * Tracheostomy or laryngectomy stoma * Hemodynamic instability requiring \>0.2mcg/kg/min of norepinepherine (or equivalent) to maintain mean arterial pressure \>65mmHg * Pre-existing "do not resuscitate" or "do not intubate" order * Home use of non-invasive positive-pressure ventilation for respiratory support of a medical condition other than sleep apnea * Transferred from another Emergency Department * History of advanced chronic obstructive pulmonary disease * History of advanced heart failure * Presence of opt-out identification * Prisoner * Known or apparent pregnant * Previous enrollment in WINDSURFER * A patient-specific contraindication makes one assigned study intervention unsafe

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome acute respiratory failure adult acute respiratory distress syndrome chronic obstructive pulmonary disease respiratory failure

As listed by the trial registrant

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

Acute hypoxic respiratory failure Acute respiratory distress syndrome (ARDS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Ohio State East Hospital

    Columbus, Ohio, 43203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.