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New gadget aims to stop breathing tube leaks and injuries

NCT ID NCT01965821

Disease control Sponsor: University Hospital, Lille 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an electronic device that automatically keeps the air pressure in a breathing tube's cuff steady. In 18 critically ill patients, the device was compared to manual checks over two 24-hour periods. The goal was to see if the device reduces dangerous over- or under-inflation, which can lead to lung infections or airway damage.

What this could mean

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

Active substance
Mallinckrodt electronic cuff pressure controller (device)
What this could lead to
If effective, this device could help prevent lung damage and infections in patients on breathing machines.
What could go wrong
This was a very small study (18 patients) and only tested the device for 24 hours. Results may not apply to all ICU patients or longer use.

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

18 people

The number who actually took part.

Start date

Oct 2013

Finished

Dec 2014

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 intubated in the ICU with a high volume / low pressure PVC-cuffed tracheal tube * Predicted duration of mechanical ventilation \> or = 48h * Age \> or = 18 years * signed informed consent Exclusion Criteria: * Contraindication for semirecumbent position * Contraindication for enteral nutrition * Pregnancy * refuse to participate to the study

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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.

Critical illness

Contacts and locations

Locations

  • ICU, Salengro Hospital, University Hospital of Lille

    Lille, Nord, 59035, France

More trials for these conditions

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