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Can body position and a belly wrap protect lungs and breathing muscles in ARDS?

NCT ID NCT05826847

Symptom relief Sponsor: University of Chile Source: ClinicalTrials.gov ↗

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 28, 2026 · Last updated Sep 29, 2026 · Updated 1 time

Summary

Researchers at the University of Chile are studying whether prone positioning or semi-recumbent positioning with thoracoabdominal binding can protect the lungs and diaphragm in adults with moderate-to-severe ARDS who have ICU-acquired weakness and are transitioning from controlled to spontaneous breathing. The trial enrolls 14 patients and measures breathing mechanics, including pendelluft magnitude and the coupling between diaphragm pressure and electrical activity. Participants are randomly assigned to different positioning strategies during a crossover phase, and the goal is to see whether these approaches reduce lung and muscle injury during ventilator weaning.

What this could mean

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

Active substance
prone positioning and thoracoabdominal binding
What this could lead to
If these positioning strategies protect the diaphragm and lungs, they could become simple, low-cost additions to ventilator-weaning protocols for ARDS patients with ICU-acquired weakness.
What could go wrong
This is a small physiological study of 14 patients at one center, so it can only show short-term effects on breathing mechanics, not whether patients actually recover faster or survive more often. Positioning and abdominal binding carry risks of discomfort, skin pressure, or reduced breathing capacity if not carefully titrated.

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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

14 people

The number who actually took part.

Started

Dec 2023

Finished

Aug 2025

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: * Adult ARDS patients with moderate-severe ARDS on controlled protective mechanical ventilation for more than 2 days (modified from "more than 3 days" by the protocol amendment approved in May 2024) * Stable hemodynamics * Level of consciousness enough to initiate spontaneous breathing Exclusion Criteria: * Unstable hemodynamics * Tracheostomy * Abnormal level of consciousness * Central nervous system injury * Esophageal varices * Pregnancy * Contraindications for installation of electrical impedance tomography or nasogastric catheter placement * Contraindications for prone positioning and thoracoabdominal binding * Chronic neuromuscular disorders * Obstructive lung disease; intrinsic positive end-expiratory pressure (PEEP) ≥3 cmH₂O (measured without inspiratory effort); * Recent-onset sepsis and moderate-to-severe metabolic acidosis; * Multi-organ failure with high short-term mortality risk * Clinical evidence of respiratory or hemodynamic instability

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome critical illness polyneuropathy

As listed by the trial registrant

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

Acute respiratory distress syndrome Icu acquired weakness Mechanical ventilation complication

Contacts and locations

Locations

  • Hospital Clínico Universidad de Chile

    Independencia, Chile

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