TRacheal Cuff PRessure Evaluation Study

NCT06848010 | Not Yet Recruiting

• 1 other identifier: TRAC-PRES
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Mechanical Ventilation; Pneumonia, Ventilator-Associated

Keywords

pressure cuff control; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Cuff Pressure

  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 Outcomes (1)

• Microaspiration

  From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation

Study Arms (2)

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.

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.

Interventions

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.

Automated endotracheal cuff controller

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

Location

Related Publications (3)

• 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.

  PMID: 32198671 BACKGROUND

• Hamilton 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.

  PMID: 22209048 BACKGROUND

• Blot 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.

  PMID: 25430629 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Zanella, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY CHAIR

Central Study Contacts

Irene Zainaghi, PhD

CONTACT

+39 0255033275; irene.zainaghi@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the completion of patients enrollement and once study data have been verified by investigators. Data will be available for undefinite time.
• Access Criteria: Researchers interested in the topic, previous authorization of the principal investigator

Locations

IT (1)