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Completed

NCT Number: NCT07423208

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

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.

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Key information

About this study

This single-center prospective cohort study enrolled consecutively screened ICU patients requiring invasive mechanical ventilation after severe head injury. Participants were allocated to exposure groups based on the ventilator to which they were connected at ICU admission, without investigator influence: (1) integrated continuous cuff pressure control via HAMILTON-C6 ventilator, or (2) intermittent manual cuff pressure checks using a manometer according to standard practice (every 8 hours and additionally during nursing/diagnostic-therapeutic procedures as needed), targeting cuff pressures of 20-30 cmH₂O.

Participants were followed for up to 7 days in ICU for development of VAP. VAP assessment used clinical, laboratory, radiological, and microbiological data summarized using the Clinical Pulmonary Infection Score (CPIS). Standard VAP prevention bundle measures were applied to both groups per unit protocol. All patients received prophylactic amoxicillin/clavulanic acid 1.2 g IV every 8 hours according to local protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Missing required assessments/results (optional to include as operational exclusion)

Treatment and study plan

Continous measurement of cuff pressure in endotracheal tube

Procedure

Group1: Integrated continuous 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.

Primary outcomes

  1. Incidence of ventilator-associated pneumonia (VAP)

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

    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

Secondary outcomes

  1. Median/average cuff pressure during ICU stay (cmH₂O)

    Time frame: from Day 3 to Day 7

    summarized per participant from recorded measurements; compare between cohorts.

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

    Time frame: from Day 3 to Day 7

    count of recorded episodes outside recommended range.

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

    Time frame: from Day 0 to discharge from the ICU

    compare cohorts in participants who developed VAP.

  4. ICU and/or hospital length of stay (days)

    Time frame: until discharge from ICU/hospital

    compare cohorts.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Comparison of the Incidence of Ventilator-Associated Pneumonia Between Integrated Mechanical Ventilator Cuff Pressure Monitoring and Manual Manometric Cuff Monitoring - A Prospective Cohort Study

Acronym: ICPM-VAP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2026
Registry last updated
Feb 20, 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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