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Can a Lung-Opening maneuver change a key injury marker in ARDS?

NCT ID NCT01600651

Knowledge-focused Sponsor: University Hospital, Clermont-Ferrand 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial investigates whether a recruitment maneuver—a brief procedure to open collapsed lung areas—affects blood levels of sRAGE, a marker of lung cell injury, in patients with diffuse acute respiratory distress syndrome (ARDS). The study involves 24 mechanically ventilated ICU patients within 24 hours of ARDS onset. Each patient receives both a real and a sham maneuver in random order, and researchers compare sRAGE levels afterward. The goal is to understand how ventilatory interventions influence lung injury, which could inform better treatment approaches.

What this could mean

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

Active substance
Recruitment maneuver (a brief lung-opening procedure during mechanical ventilation)
What this could lead to
If successful, this could clarify whether recruitment maneuvers influence lung injury markers, potentially guiding safer ventilation strategies for ARDS patients.
What could go wrong
This is a small, early-phase study (24 patients) focused on a biomarker, not clinical outcomes. Results may not generalize, and the maneuver carries risks like lung injury or bacterial spread.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

24 people

The number who actually took part.

Start date

Apr 2012

Finished

Oct 2013

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: * ICU patients under mechanical ventilation * Patients within the first 24 hours after onset of ARDS according to the 1994 American-European Consensus Conference (AECC) * PaO2/FiO2 ratio \< 200 with external PEEP \>5 cmH2O * "Nonfocal" loss of aeration based on CT scan lung morphology analysis, as defined by the "CT scan ARDS study group" criteria Exclusion Criteria: * Pregnancy * Acute exacerbation of diabetes * Dialysis for end-stage kidney disease * Alzheimer's disease * Amyloidosis * Evolutive neoplastic lesion * Known or suspected history of allergy to cisatracurium * Chronic respiratory disease requiring long term oxygen therapy or long term ventilation * Confirmed or suspected elevated intracranial pressure * Confirmed or suspected bronchopleural fistula, pneumothorax * Persistent hemodynamic instability despite appropriate resuscitation

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

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

Acute respiratory distress syndrome

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

More trials for these conditions

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