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Pilot study to test best ventilator approach for severe lung failure

NCT ID NCT07463885

Knowledge-focused Sponsor: Oslo University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study will enroll 80 ICU patients with acute hypoxemic respiratory failure to compare two ventilator strategies: one that allows patients to breathe spontaneously and one that fully controls their breathing. The goal is to see if a larger trial is possible and to gather early data on outcomes. The study is not yet recruiting and is led by Oslo University Hospital.

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 design a larger trial that may identify the best ventilation strategy for patients with acute respiratory failure.
What could go wrong
This is a small, early feasibility study, not designed to prove which ventilation method is better. Results may not change practice directly.

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 80 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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: We will include patients who fulfil all the following criteria: * Acutely admitted to the ICU * AND age ≥ 18 years * AND invasive mechanical ventilation via endotracheal tube or tracheostomy for less than 24 hours * AND moderate acute hypoxemic respiratory failure, defined as a PaO₂-FiO₂ ratio between 13.3-26.6 kPa (100-200 mmHg) with PEEP ≥ 5 cm H2O, based on arterial blood gas analysis obtained within 2 hours before randomisation. * AND new pulmonary infiltrate (uni- or bilateral) on chest x-ray or CT-scan obtained no more than 24 hours before randomisation. Exclusion Criteria: * Previously randomised into the SVALBARD trial. * Informed consent following inclusion expected to be unobtainable * Patient under coercive measures * Withdrawal from active therapy or brain death deemed imminent. * Chronic hypercapnic respiratory failure defined as PaCO2 \> 8 kPa (60 mm Hg) in the outpatient setting. * Listed for lung transplant. * Acute heart failure / acute myocardial infarction / cardiac arrest during or causing index ICU admission. * Use of home oxygen. * Chronic mechanical ventilation for any reason except for non-invasive mechanical ventilation (CPAP/BIPAP) used solely for sleep apnoea disorder. * Currently receiving ECMO therapy. * Burns \>70 % total body surface. * Acute brain injury or stroke (any, including subarachnoid haemorrhage, SAH). * Intracranial hypertension. * Patients with planned repeat surgical interventions during current stay in ICU.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome acute respiratory failure adult acute respiratory distress syndrome respiratory failure

As listed by the trial registrant

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

Acute hypoxemic respiratory failure Acute respiratory distress syndrome (ARDS)

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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