Pneumonia, Ventilator-AssociatedTRAC-PRESNCT06848010
TRacheal Cuff PRessure Evaluation Study
A study of Pneumonia, Ventilator-Associated and Mechanical Ventilation, run by Policlinico Hospital at 1 site in Italy.
Trial summary
Randomized clinical trial in mechanically ventilate critically ill patients. The study will evaluated the efficacy of a continous endotracheal tube (ETT) cuff pressure controller (TRACH FLUSH group) compared to manual monitoring and inflation (STANDARD group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Mechanical Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Required invasive mechanical ventilation expected to last for more than 24h
- Signed informed consent
Who cannot join
- Intubated from more than 6 hours at the time of screening
- Pregnancy
- Previous surgery involving the airways
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milan, 20122
About this study
Randomized clinical trial in mechanically ventilate critically ill patients. The study will evaluated the efficacy of a continous endotracheal tube (ETT) cuff pressure controller (TRACH FLUSH group) compared to manual monitoring and inflation (STANDARD group).
Patients intubated, from at least 24 hours and with a predicted duration of invasive mechanical ventilation longer than 72 hours, will be randomized to the use of TRACH FLUSH versus nurse operated analogic cuff pressure controller q8.
Read more
Hypotesis of the study is the superiority of the continuous cuff pressure controller in maintaining cuff pressure within the target value, thus decreasing the incidence of microaspiration events.
Aim of the study are 1) to compare the incidence of cuff pressure value detection outside the target range between the TRACH FLUSH and the STANDARD group, and 2) to compare the incidence of sputum samples positive for (amylase and/or pepsin), a surrogate for tracheal micro-aspiration event.
Read the detailed description
Endotracheal intubation is an effective method of providing rapid and safe airway patency and respiratory support in the intensive care unit (ICU). Endotracheal intubation effectively isolates the trachea by inflating the endotracheal tube (ETT) cuff just below the vocal cords: this ensures airway patency and positive pressure ventilation. The pressure of the endotracheal tube cuff (Pcuff) should be between 20-30 cmH2O to ensure airway isolation. The literature reports that overinflation of the endotracheal cuff (>30 cmH2O) causes hoarseness, sore throat, inadequate swallowing of secretions, tracheal stenosis, tracheal wall damage, and ischemia due to decreased mucosal capillary blood flow: these changes can occur even if a high Pcuff is maintained for a short period of time. In contrast, inadequate inflation (less than 20 cmH2O) results in ventilation-associated pneumonia (VAP) due to ineffective ventilation and microaspiration of gastric and/or oropharyngeal secretions into the lungs. Risk factors for microaspiration include patient-related factors, factors related to endotracheal tube type, performance of invasive procedures such as enteral nutrition through a nasogastric or orogastric tube, and mechanical ventilation. Patient-related factors include supine position, sedation, coma, tracheal diameter, and viscosity of secretions, while among those related to tube type we find impossible vocal cord closure, longitudinal folds of low-pressure and high-volume polyvinyl chloride (PVC) tracheal tubes. The American Association of Critical-Care Nurses (AACN) states that in order to achieve adequate pressure and prevent mucosal damage, the amount of pressure and volume of air needed, the size, shape of the tube, mode of mechanical ventilation, and the patient's blood pressure must be taken into account.
The methods found in ICUs to control Pcuff and keep it within safe ranges are about a dozen and range from manual external palpation of the inflation balloon, to assessment of inspiratory/expiratory volume loss to continuous monitoring with appropriate instrumentation.
Despite the known Pcuff-related complications of ETT, there is a paucity of national or international guidelines on the optimal pressure value, frequency of pressure measurement, and measurement methods: however, some studies performed show that the use of an automated device that continuously monitors Pcuff significantly decreases gastric microaspirations.
- Being tested
- Automated endotracheal cuff controller
- Keywords
- pressure cuff control, mechanical ventilation
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated endotracheal cuff controllerDevice
The automated endotracheal tube cuff pressure controller will continously assess and maintain the endotracheal tube cuff pressure at pre-specifed pressure level of 25 cmH20.
| Study group | Role | What they receive |
|---|---|---|
| Automated endotracheal cuff controller | Experimental | The endotracheal tube cuff pressure will be continuously controlled by the Trachflush system, at pre-specifed pressure level of 25 cmH20. Receives: Device: Automated endotracheal cuff controller |
| Control group (analogic manometer) | No intervention | The endotracheal cuff will be inflated at 25 cmH20 manually by an analogic manometer. Every 8 hours analogic manometry will be performed to assess cuff pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuff Pressure
Incidence of measurements with a endotracheal cuff pressure outside the prespecified target value: 25 cmH2O
Measured: From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation
Secondary outcomes (1)
Microaspiration
Incidence of detection of detectable levels of Pepsin A and Amylase in the tracheal secretions samples. Daily sampling of tracheal secretions will be performed at 8:00AM.
Measured: From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start15 Feb 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
- Investigators
- Alberto Zanella, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848010
- Sponsor's protocol ID
- TRAC-PRES
- Acronym
- TRAC-PRES
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data regarding characteristics of patients enrolled, treatment performed and outcome will be available.
Publications
Kumar CM, Seet E, Van Zundert TCRV. Measuring endotracheal tube intracuff pressure: no room for complacency. J Clin Monit Comput. 2021 Feb;35(1):3-10. doi: 10.1007/s10877-020-00501-2. Epub 2020 Mar 20.
PubMed 32198671Hamilton VA, Grap MJ. The role of the endotracheal tube cuff in microaspiration. Heart Lung. 2012 Mar-Apr;41(2):167-72. doi: 10.1016/j.hrtlng.2011.09.001. Epub 2011 Dec 30.
PubMed 22209048Blot SI, Poelaert J, Kollef M. How to avoid microaspiration? A key element for the prevention of ventilator-associated pneumonia in intubated ICU patients. BMC Infect Dis. 2014 Nov 28;14:119. doi: 10.1186/1471-2334-14-119.
PubMed 25430629
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRacheal Cuff PRessure Evaluation Study
- ClinicalTrials.gov ID
- NCT06848010
- Acronym / sponsor ID
- TRAC-PRES / TRAC-PRES
- Keywords
- pressure cuff control, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Feb 2025 (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.
Randomized clinical trial in mechanically ventilate critically ill patients. The study will evaluated the efficacy of a continous endotracheal tube (ETT) cuff pressure controller (TRACH FLUSH group) compared to manual monitoring and inflation (STANDARD group).
Patients intubated, from at least 24 hours and with a predicted duration of invasive mechanical ventilation longer than 72 hours, will be randomized to the use of TRACH FLUSH versus nurse operated analogic cuff pressure controller q8.
Hypotesis of the study is the superiority of the continuous cuff pressure controller in maintaining cuff pressure within the target value, thus decreasing the incidence of microaspiration events.
Aim of the study are 1) to compare the incidence of cuff pressure value detection outside the target range between the TRACH FLUSH and the STANDARD group, and 2) to compare the incidence of sputum samples positive for (amylase and/or pepsin), a surrogate for tracheal micro-aspiration event.
Detailed description
Endotracheal intubation is an effective method of providing rapid and safe airway patency and respiratory support in the intensive care unit (ICU). Endotracheal intubation effectively isolates the trachea by inflating the endotracheal tube (ETT) cuff just below the vocal cords: this ensures airway patency and positive pressure ventilation. The pressure of the endotracheal tube cuff (Pcuff) should be between 20-30 cmH2O to ensure airway isolation. The literature reports that overinflation of the endotracheal cuff (>30 cmH2O) causes hoarseness, sore throat, inadequate swallowing of secretions, tracheal stenosis, tracheal wall damage, and ischemia due to decreased mucosal capillary blood flow: these changes can occur even if a high Pcuff is maintained for a short period of time. In contrast, inadequate inflation (less than 20 cmH2O) results in ventilation-associated pneumonia (VAP) due to ineffective ventilation and microaspiration of gastric and/or oropharyngeal secretions into the lungs. Risk factors for microaspiration include patient-related factors, factors related to endotracheal tube type, performance of invasive procedures such as enteral nutrition through a nasogastric or orogastric tube, and mechanical ventilation. Patient-related factors include supine position, sedation, coma, tracheal diameter, and viscosity of secretions, while among those related to tube type we find impossible vocal cord closure, longitudinal folds of low-pressure and high-volume polyvinyl chloride (PVC) tracheal tubes. The American Association of Critical-Care Nurses (AACN) states that in order to achieve adequate pressure and prevent mucosal damage, the amount of pressure and volume of air needed, the size, shape of the tube, mode of mechanical ventilation, and the patient's blood pressure must be taken into account.
The methods found in ICUs to control Pcuff and keep it within safe ranges are about a dozen and range from manual external palpation of the inflation balloon, to assessment of inspiratory/expiratory volume loss to continuous monitoring with appropriate instrumentation.
Despite the known Pcuff-related complications of ETT, there is a paucity of national or international guidelines on the optimal pressure value, frequency of pressure measurement, and measurement methods: however, some studies performed show that the use of an automated device that continuously monitors Pcuff significantly decreases gastric microaspirations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated endotracheal cuff controller | Experimental | Device: Automated endotracheal cuff controllerThe endotracheal tube cuff pressure will be continuously controlled by the Trachflush system, at pre-specifed pressure level of 25 cmH20. |
| Control group (analogic manometer) | No intervention | –The endotracheal cuff will be inflated at 25 cmH20 manually by an analogic manometer. Every 8 hours analogic manometry will be performed to assess cuff pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Required invasive mechanical ventilation expected to last for more than 24h
- Signed informed consent
Key exclusion criteria (3 listed)
- Intubated from more than 6 hours at the time of screening
- Pregnancy
- Previous surgery involving the airways
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 |
|---|---|---|
| Automated endotracheal cuff controllerThe automated endotracheal tube cuff pressure controller will continously assess and maintain the endotracheal tube cuff pressure at pre-specifed pressure level of 25 cmH20. | Device | Automated endotracheal cuff controller |
Primary outcome
Cuff Pressure
Time frame: From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation
Incidence of measurements with a endotracheal cuff pressure outside the prespecified target value: 25 cmH2O
1 secondary outcome
Microaspiration
Time frame: From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 32198671Kumar CM, Seet E, Van Zundert TCRV. Measuring endotracheal tube intracuff pressure: no room for complacency. J Clin Monit Comput. 2021 Feb;35(1):3-10. doi: 10.1007/s10877-020-00501-2. Epub 2020 Mar 20.
- Background: PubMed 22209048Hamilton VA, Grap MJ. The role of the endotracheal tube cuff in microaspiration. Heart Lung. 2012 Mar-Apr;41(2):167-72. doi: 10.1016/j.hrtlng.2011.09.001. Epub 2011 Dec 30.
- Background: PubMed 25430629Blot SI, Poelaert J, Kollef M. How to avoid microaspiration? A key element for the prevention of ventilator-associated pneumonia in intubated ICU patients. BMC Infect Dis. 2014 Nov 28;14:119. doi: 10.1186/1471-2334-14-119.
- Individual participant dataSharing planned: Yes. Data regarding characteristics of patients enrolled, treatment performed and outcome will be available.
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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.
Alberto Zanella, MD study chair
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pneumonia, Ventilator-Associated and Mechanical Ventilation, run by Policlinico Hospital at 1 site in Italy.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Jan 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Zainaghi, PhD (+39 0255033275, irene.zainaghi@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cuff Pressure (time frame: From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation). 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 NCT06848010, which also lists 3 linked publications.
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 28 Jan 2026.