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New breathing tube strategy aims to prevent lung collapse in ventilated patients

NCT ID NCT05526053

Knowledge-focused Sponsor: Althaia Xarxa Assistencial Universitària de Manresa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two ways of taking patients off a mechanical ventilator to see which leads to more successful removals. One method used a standard breathing trial without extra pressure, while the other kept the lungs slightly inflated during the trial and removed the tube without suctioning. Over 1,700 adults on ventilators for more than 24 hours took part. The goal was to find out if preserving lung volume reduces breathing tube failure and lung collapse.

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 could lead to a simple change in how patients are taken off ventilators, reducing breathing tube failures and lung collapse.
What could go wrong
This is an early-stage comparison of two techniques, not a new drug or device. Results may not apply to all patients or settings.

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

1,753 people

The number who actually took part.

Started

Jan 2023

Finished

Aug 2024

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: * Patients\> 18 years who meet weaning criteria (see below) * More than 24 hours of mechanical ventilation (MV) * Signed Informed Consent by a substitute decision maker (SDM). Weaning Criteria: * Suitable cough (Ability to raise secretions to the endotracheal tube) (or Maximal inspiratory pressure (MIP) \< -15 cmH2O). * Absence of excessive secretions (\<3 aspirations in the last 8 hours). * Resolution or improvement of the pathology that led to intubation. * Clinical stability (Heart Rate (HR) \<140 bpm, Systolic Blood Pressure (SBP) 90-160, without vasopressors or at minimum doses). * Adequate oxygenation (SatO2\> 90% with Inspiratory Fraction of oxygen (FiO2) \<0.4). * Adequate ventilatory mechanics (Respiratory rate (RR) \<35 rpm, Tidal Volume (TV) \> 5 ml / kg, RR / TV \<100 rpm/l). * Confident awareness level (Glasgow Coma Scale (GCS)\> 13). Exclusion Criteria: * tracheostomy, do-not-reintubate orders, decision of the responsible physician (e.g., due to a preference for a particular weaning technique according to the underlying pathology), absence of informed consent, mental incapacity without legal representation. * For ultrasound assessment: skilled explorer not present at the time of the SBT, inadequate ultrasound window. Known diaphragmatic paralysis.

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Conditions

The condition(s) this trial relates to.

Pulmonary Atelectasis

As listed by the trial registrant

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

Pulmonary collapse Weaning failure

Contacts and locations

Locations

  • Althaia Xarxa Assistencial

    Manresa, Bacelona, 08243, Spain

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