Integrated vs Manual Endotracheal Tube Cuff Pressure Monitoring and Ventilator-Associated Pneumonia

NCT07423208 | Completed

• 2 other identifiers: UMCLJ-ICU-VAP-CUFF-2021-010120-119/2021/10
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilator-associated pneumonia (VAP) is a frequent complication in mechanically ventilated patients in intensive care unit (ICU). This prospective cohort study compares the incidence of VAP between patients whose endotracheal tube cuff pressure was controlled continuously using an integrated ventilator cuff-pressure control system versus intermittent manual manometric monitoring performed by staff.

Conditions

Ventilator Associated Pneumonia ( VAP); Intensive Care (ICU)

Keywords

Intensive Care Units; Ventilators, Mechanical; Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

• Incidence of ventilator-associated pneumonia (VAP)

  VAP occurrence defined by CPIS threshold ≥7 (scale range 0-12), incorporating clinical parameters (temperature, tracheal secretions), laboratory leukocyte count, oxygenation (PaO₂/FiO₂), chest radiography findings, and microbiology

  From Day 3 to Day 7 (assessed on days 3, and 7; VAP defined as onset >48-72 hours after initiation of invasive ventilation)

Secondary Outcomes (4)

• Median/average cuff pressure during ICU stay (cmH₂O)

  from Day 3 to Day 7

• Number of cuff-pressure events outside target range (<20 or >30 cmH₂O)

  from Day 3 to Day 7

• Duration of mechanical ventilation among VAP-positive participants (hours)

  from Day 0 to discharge from the ICU

• ICU and/or hospital length of stay (days)

  until discharge from ICU/hospital

Study Arms (2)

Cohort 1: Integrated cuff pressure control

Description Endotracheal tube cuff pressure continuously controlled and recorded by the ventilator's integrated cuff pressure control function (HAMILTON-C6)

Procedure: Continous measurement of cuff pressure in endotracheal tube

Cohort 2: Manual manometric cuff pressure monitoring

Description Endotracheal tube cuff pressure monitored by staff using a manometer, checked at least every 8 hours and additionally during routine nursing procedures and diagnostic/therapeutic interventions, targeting 20-30 cmH₂O.

Procedure: Intermittent manual cuff pressure monitoring with manometer.

Interventions

Continous measurement of cuff pressure in endotracheal tube PROCEDURE

Group1: Integrated continuous cuff pressure control

Cohort 1: Integrated cuff pressure control

Intermittent manual cuff pressure monitoring with manometer. PROCEDURE

Endotracheal tube cuff pressure monitored by staff using a manometer, checked at least every 8 hours and additionally during routine nursing procedures and diagnostic/therapeutic interventions, targeting 20-30 cmH₂O.

Cohort 2: Manual manometric cuff pressure monitoring

Eligibility Criteria

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

Study Population

Intensive care patients

You may qualify if:

• ICU admission after severe head injury
• Endotracheal intubation and invasive mechanical ventilation
• Expected mechanical ventilation \>48-72 hours (recommended to add for PRS clarity)
• Informed consent from family/legal representative

You may not qualify if:

• Pneumonia/VAP diagnosed within the first 48 hours of ICU admission/ventilation
• Removal or replacement of endotracheal tube during observation window
• Tracheotomy performed within 7 days of admission

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre

Ljubljana, Slovenia

Location

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

• Primoz Gradisek

  University Medical centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 20, 2026
• Study Start: December 1, 2021
• Primary Completion: January 7, 2024
• Study Completion: February 1, 2024
• Last Updated: February 20, 2026

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Available beginning \[e.g., 6 months\] after publication/primary results dissemination, for \[e.g., 5 years\].
• Access Criteria: Available upon reasonable request to the corresponding investigator, with a methodologically sound proposal and data use agreement.

Locations

SL (1)