Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Helmet vs. mask vs. oxygen: which keeps patients off breathing tubes?

NCT ID NCT05089695

Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests three ways to help patients with severe low oxygen levels breathe better without needing a breathing tube. About 1,200 adults will be randomly assigned to receive either a helmet mask that pushes air, a helmet mask that keeps airways open, or high-flow oxygen through the nose. The goal is to see which method reduces the need for a breathing tube and helps patients recover faster.

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 1,200 people

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

Started

Mar 2022

Expected to finish

Jun 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: * Acute symptoms of respiratory failure PaO2/FiO2 ratio ≤ 200; PaCO2≤45mmHg; Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency (NYHA\>2 or left ventricular ejection fraction\<50%); Informed consent Patients that have already received NIV, CPAP continuously for more than 24 hours before the screening visit will be excluded. Other Exclusion Criteria: * Pregnancy; * Exacerbation of asthma or chronic obstructive pulmonary disease; * Hypercapnia (PaCO2\>45 mmHg) with or without respiratory acidosis; * More than 2 organ failures, including the lung. * Documented pneumothorax; * Clinical diagnosis of Cardiogenic pulmonary edema; * Haemodynamic instability (Systolic blood pressure\<90 mmHg or mean arterial pressure\<65mmHg) and/or lactic acidosis (lactate\>5 mmol/L) and/or clinically diagnosed Shock requiring administration of vasoactive agents (norepinephrine\>0.1 mcg/Kg/min); * Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia); * Chronic kidney failure requiring dialysis before ICU admission; * Chronic hypoxemic respiratory failure requiring long-term oxygen therapy; * Altered neurological status that requires immediate intubation and/or making the patient uncooperative; * Urgent need for endotracheal intubation, according to the decision of the attending physician; * Do not intubate order; * Decision of withdrawal of life-sustaining therapy; * Thoracic or abdominal surgery in the previous 7 days; * Any condition that makes the patient very likely to require endotracheal intubation due to a reason different from respiratory failure; * Recent head surgery or anatomy that prevent the application of helmet or HFNC to patient's face.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute hypoxemic respiratory failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Hypoxemic respiratory failure Respiratory failure

How to take part

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

  1. The places running it

    1 site. 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

  • Gemelli

    RECRUITING

    Rome, Italy

More trials for these conditions

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