Can a simple device keep breathing tubes sealed and cut pneumonia risk?
NCT ID NCT03330379
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Patients on a breathing machine need the cuff around their endotracheal tube kept at about 25 cmH2O to seal the airway. Nurses usually check and adjust this pressure by hand every few hours, which can let the pressure drop too low between checks. This trial tests whether a mechanical device called the Tracoe Smart Cuffmanager, which adjusts cuff pressure continuously, lowers the number of times pressure falls below 20 cmH2O compared with standard intermittent checks. Researchers will study 60 adults with severe acute brain injury who are expected to need a breathing tube for at least two days in the intensive care unit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tracoe Smart Cuffmanager, a mechanical device that continuously controls endotracheal tube cuff pressure
- What this could lead to
- If it works, continuous cuff pressure control could become a standard way to keep breathing tubes properly sealed and lower the risk of lung infections in intensive care.
- What could go wrong
- This is a small, single-center study of 60 patients with severe brain injury, so the results may not apply to other intensive care patients. The device could fail to reduce underinflation or could cause overinflation, and the trial may not show a clear difference.
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
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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
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60 people
The number who actually took part.
- Started
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Mar 2018
- Finished
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Jul 2019
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * with severe acute brain damage * admitted in the ICU for less than 48 hours * and expected to receive invasive mechanical ventilation (through orotracheal tube with a low pressure-high volume cuff) for at least 48 hours after inclusion. Exclusion Criteria: * change in the upper airway management within the 48 hours following the inclusion (extubation or change in the tracheal tube or tracheostomy) * pregnancy, moribund status.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chu de Nantes
Nantes, 44093, France
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Other studies related to the condition(s) this trial covers.
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