Acute Brain InjuryCONTIPRESSNCT03330379
Comparison of Two Strategies for Endotracheal Tube Cuff Underinflation Prevention During Invasive Mechanical Ventilation
A study testing Tracoe Smart CuffmanagerTM in people with Acute Brain Injury and Brain Injuries, run by Nantes University Hospital at 1 site in France.
Trial summary
During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury, Brain Injuries
- What is being tested?
- Tracoe Smart CuffmanagerTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Strategies for the Prevention of Endotracheal Tube Cuff Underinflation During Invasive Mechanical Ventilation: Intermittent Versus Continuous Cuff Pressure Control - A Randomised Controlled Study
During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.
Read the detailed description
During invasive mechanical ventilation, maintaining a tracheal cuff pressure (Pcuff) around 25 cmH2O is recommended to prevent cuff over- (> 30 cmH2O) and underinflation (< 20 cmH2O), identified as risk factors for tracheal ischemic damage and for oropharyngeal microaspirations, respectively. Intermittent measurements with intermittent adjustments of Pcuff is the widely used strategy but, between measurements, over- and underinflation episodes could occur. Devices allowing a continuous control of Pcuff are therefore appealing. As microaspiration is the most relevant mechanism for ventilator-associated pneumonia (VAP), the use of such devices may decrease the incidence of VAP for instance. To the knowledge of the investigators, the continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control. As secondary objectives, the investigators aim to assess the impact of the use of the Tracoe Smart CuffmanagerTM on the incidence of overinflation episodes and on the incidence of early ventilator-associated pneumonia. A homogenous population will be studied for this purpose: patients admitted with severe acute brain damage.
- Conditions
- Acute Brain Injury, Brain Injuries
- Being tested
- Tracoe Smart CuffmanagerTM
- Keywords
- Endotracheal tube, ventilator's associated pneumonia, intensive care unit, orotracheal intubation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracoe Smart CuffmanagerTMDevice
In patients randomly assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff. Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments
| Study group | Role | What they receive |
|---|---|---|
| continuous adjustment strategy | Experimental | patients assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff Receives: Device: Tracoe Smart CuffmanagerTM |
| usual care | No intervention | patients with usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of underinflation episodes
The primary outcome is to test whether the Tracoe Smart CuffmanagerTM reduces the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control. Therefore, a comparison, between the 2 groups, of the incidence of Pcuff <20 cmH2O measurements will be performed.
Time Frame: Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments
Measured: Day2
Secondary outcomes (5)
incidence of Pcuff >30 cmH2O measurements (overinflation episodes)
As secondary objective, a comparison, between the 2 groups, of the incidence of Pcuff >30 cmH2O measurements (overinflation episodes) will be performed.
Furthermore, the incidence of early ventilator-associated pneumonia will be compared between the 2 groups.
Measured: Within the 2 days following the inclusion
Duration of mechanical ventilation
Measured: Within the 2 days following the inclusion
ICU length of stay
Measured: Within the 2 days following the inclusion
ICU mortality
Measured: Within the 2 days following the inclusion
occurrence of early ventilator-associated pneumonia
Measured: During the first two weeks of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Mar 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme Dauvergne, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330379
- Sponsor's protocol ID
- RC16_0390
- Acronym
- CONTIPRESS
- Status last verified
- Aug 2019
- First submitted
- 31 Oct 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dauvergne JE, Geffray AL, Asehnoune K, Rozec B, Lakhal K. Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study. Anaesth Crit Care Pain Med. 2020 Jun;39(3):435-441. doi: 10.1016/j.accpm.2020.04.007. Epub 2020 May 4.
PubMed 32376293
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies for the Prevention of Endotracheal Tube Cuff Underinflation During Invasive Mechanical Ventilation: Intermittent Versus Continuous Cuff Pressure Control - A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03330379
- Acronym / sponsor ID
- CONTIPRESS / RC16_0390
- Conditions
- Acute Brain Injury, Brain Injuries
- Keywords
- Endotracheal tube, ventilator's associated pneumonia, intensive care unit, orotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.
Detailed description
During invasive mechanical ventilation, maintaining a tracheal cuff pressure (Pcuff) around 25 cmH2O is recommended to prevent cuff over- (> 30 cmH2O) and underinflation (< 20 cmH2O), identified as risk factors for tracheal ischemic damage and for oropharyngeal microaspirations, respectively. Intermittent measurements with intermittent adjustments of Pcuff is the widely used strategy but, between measurements, over- and underinflation episodes could occur. Devices allowing a continuous control of Pcuff are therefore appealing. As microaspiration is the most relevant mechanism for ventilator-associated pneumonia (VAP), the use of such devices may decrease the incidence of VAP for instance. To the knowledge of the investigators, the continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control. As secondary objectives, the investigators aim to assess the impact of the use of the Tracoe Smart CuffmanagerTM on the incidence of overinflation episodes and on the incidence of early ventilator-associated pneumonia. A homogenous population will be studied for this purpose: patients admitted with severe acute brain damage.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous adjustment strategy | Experimental | Device: Tracoe Smart CuffmanagerTMpatients assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff |
| usual care | No intervention | –patients with usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracoe Smart CuffmanagerTMIn patients randomly assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff. Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments | Device | continuous adjustment strategy |
Primary outcome
Incidence of underinflation episodes
Time frame: Day2
The primary outcome is to test whether the Tracoe Smart CuffmanagerTM reduces the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control. Therefore, a comparison, between the 2 groups, of the incidence of Pcuff <20 cmH2O measurements will be performed. Time Frame: Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments
5 secondary outcomes
incidence of Pcuff >30 cmH2O measurements (overinflation episodes)
Time frame: Within the 2 days following the inclusion
Duration of mechanical ventilation
Time frame: Within the 2 days following the inclusion
ICU length of stay
Time frame: Within the 2 days following the inclusion
ICU mortality
Time frame: Within the 2 days following the inclusion
occurrence of early ventilator-associated pneumonia
Time frame: During the first two weeks of hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 32376293Dauvergne JE, Geffray AL, Asehnoune K, Rozec B, Lakhal K. Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study. Anaesth Crit Care Pain Med. 2020 Jun;39(3):435-441. doi: 10.1016/j.accpm.2020.04.007. Epub 2020 May 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Dauvergne principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracoe Smart CuffmanagerTM in people with Acute Brain Injury and Brain Injuries, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of underinflation episodes (time frame: Day2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.