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New study tests if video laryngoscopy makes tracheostomy safer

NCT ID NCT05416489

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compares two methods for removing and repositioning the breathing tube during a tracheostomy in ICU patients: using a video laryngoscope (C-MAC) versus a standard laryngoscope. The goal is to see which method reduces the risk of puncturing the tube's cuff, which can cause breathing problems. About 90 adult ICU patients needing a tracheostomy will be randomly assigned to one of the two techniques.

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 show that videolaryngoscopy reduces complications like cuff puncture during tracheostomy, improving patient safety.
What could go wrong
This is a small, early-stage trial with only 90 participants, so results may not apply to all ICU patients. The benefit over standard care may be small.

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 90 people

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

Started

Jan 2022

Expected to finish

Jun 2026

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 to 85 years

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 intubated patients that require a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure). Exclusion Criteria: * Patients younger than 18 years and older than 85 years * Trachea and neck abnormalities. * Soft tissue infection in the neck. * History of neck surgery. * Coagulation disorders or changes in coagulation parameters (platelet count \< 50.000 mm3, an activated partial thromboplastin time 1.5-fold longer than the control value, and international normalized ratio \> 1.5). * Consent refusal for participating in the trial.

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • University Clinical Hospital of Santiago de Compostela

    RECRUITING

    Santiago de Compostela, A Coruña, 15866, Spain

  • University Clinical Hospital of Santiago de Compostela

    RECRUITING

    Santiago de Compostela, A Coruña, 15866, Spain

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