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NCT Number: NCT06848010

TRacheal Cuff PRessure Evaluation 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated endotracheal cuff controller

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Zainaghi, PhD

CONTACT

[email protected]

+39 0255033275

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Acronym: TRAC-PRES

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 26, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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