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New breathing test may predict readiness for tracheostomy removal

NCT ID NCT07810166

Diagnosis Sponsor: Pontificia Universidad Catolica de Chile 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Critically ill patients with a tracheostomy need a reliable test to show they can breathe through the nose and mouth before the tube is removed. The standard capping trial blocks the tube, but the tube itself narrows the airway and may make breathing seem harder than it will be after removal. This study compares the capping trial with a new method that adds extra tubing to mimic the breathing effort after decannulation. Each participant tries both methods in random order, and researchers measure breathing effort and muscle activity to see which test better predicts actual breathing after the tube comes out.

What this could mean

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

Active substance
Incremental instrumental dead space and capping trial
What this could lead to
If the dead space method predicts breathing after tube removal more accurately, it could help doctors decide sooner when a tracheostomy tube can be safely removed.
What could go wrong
This is a small physiological study with 22 participants, so the findings may not apply to all patients. The dead space method is experimental and could be uncomfortable or fail to predict outcomes better than the standard capping trial.

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 22 people

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

Started

Aug 2026

Expected to finish

Dec 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: * Adult patients (≥18 years) admitted to the ICU. * Presence of a tracheostomy due to prolonged mechanical ventilation (≥14 days). * Clinically considered ready for decannulation, according to institutional criteria (e.g., stable gas exchange, minimal secretions, effective cough, and tolerance to spontaneous breathing). * Ability to maintain spontaneous breathing without mechanical ventilation for more than 48 consecutive hours. * Able to cooperate and follow basic commands (RASS between -1 and +1). * Written informed consent obtained from patient. Exclusion Criteria: * Neuromuscular disease affecting respiratory muscles (e.g., myasthenia gravis, Guillain-Barre syndrome, amyotrophic lateral sclerosis). * Hemodynamic instability. * Severe agitation or delirium precluding cooperation (RASS \< -2 or \> +2). * Structural airway abnormalities (e.g., subglottic stenosis, tracheomalacia). * Pregnancy. * Contraindications for esophageal balloon catheter insertion (e.g., severe coagulopathy, esophageal varices, and history of esophageal or gastric surgery). * Refusal to participate by the attending physician.

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

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

Prolonged mechanical ventilation Tracheostomy Tracheostomy decannulation

How to take part

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  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

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Contacts and locations

Locations

  • Hospital Clínico UC CHRISTUS, Unidad de Paciente Crítico

    RECRUITING

    Santiago, Santiago Metropolitan, Chile

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