TRacheal Cuff PRessure Evaluation Study (TRAC-PRES)

January 26, 2026 updated by: Giacomo Grasselli, Policlinico Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milan
      • Milan, Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Required invasive mechanical ventilation expected to last for more than 24h
  • Signed informed consent

Exclusion Criteria:

  • Intubated from more than 6 hours at the time of screening
  • Pregnancy
  • Previous surgery involving the airways

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automated endotracheal cuff controller
The endotracheal tube cuff pressure will be continuously controlled by the Trachflush system, at pre-specifed pressure level of 25 cmH20.
Device: Automated endotracheal cuff controller
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.
No Intervention: Control group (analogic manometer)
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microaspiration
Time Frame: From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation
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.
From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico Hospital

Investigators

  • Study Chair: Alberto Zanella, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAC-PRES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data regarding characteristics of patients enrolled, treatment performed and outcome will be available.

IPD Sharing Time Frame

After the completion of patients enrollement and once study data have been verified by investigators. Data will be available for undefinite time.

IPD Sharing Access Criteria

Researchers interested in the topic, previous authorization of the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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