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New study aims to personalize ventilator settings for lung injury patients

NCT ID NCT07603310

Knowledge-focused Sponsor: Hospital Dr. Franco Ravera Zunino Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This study looks at two different methods for setting the pressure on a breathing machine (ventilator) in people with a serious lung condition called ARDS. The goal is to see which method improves oxygen levels better over 24 hours. About 52 adults with moderate to severe ARDS will take part. The findings may help doctors choose the best ventilator settings for each patient.

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 52 people

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

Started

Jun 2026

Expected to finish

Sep 2027

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: * Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: acute onset, bilateral opacities not fully explained by heart failure or fluid overload, and Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen \<= 200 mmHg with Positive End-Expiratory Pressure (PEEP) \>= 5 cmH2O. * ARDS duration \< 36 hours since fully meeting Berlin consensus criteria. * Relative hemodynamic stability: absence of refractory shock, defined as norepinephrine dose \<= 0.5 mcg/kg/min. Exclusion Criteria: * Evidence of active pulmonary air leaks (bronchopleural fistula, pneumothorax, pneumomediastinum). * Severe uncorrected hemodynamic instability (norepinephrine \> 0.5 mcg/kg/min). * Contraindications for esophageal balloon placement (esophageal obstruction, known perforation, recent esophageal surgery, severe esophagitis). * Elevated intracranial pressure or conditions where hypercapnia-induced increases in intracranial pressure must be avoided (intracranial hemorrhage, cerebral contusion, cerebral edema, mass effect with midline shift on CT). * Known pregnancy. * Severe coagulopathy (platelet count \< 5,000/uL or INR \> 3). * Airway opening pressure higher than 15 cmH2O (AOP \> 15 cmH2O). * History of severe neuromuscular disease or chronic respiratory disease. * Having received invasive mechanical ventilation for more than 96 hours. * Inability to obtain informed consent or refusal by the legal representative. * Contained laparotomy (open abdomen).

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory distress syndrome adult acute respiratory distress syndrome Ventilator-Induced Lung Injury

As listed by the trial registrant

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

ARDS (acute respiratory distress syndrome)

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

  • Dr. Franco Ravera Zunino Hospital

    RECRUITING

    Rancagua, Región del Libertador General Bernardo O’Higgins, 2820000, Chile

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