University Medical Centre
Ljubljana, Slovenia
NCT Number: NCT07423208
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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Notify Me18 year and older
All sexes
Observational
Ljubljana, Slovenia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group1: Integrated continuous cuff pressure control
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.
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
Time frame: from Day 3 to Day 7
summarized per participant from recorded measurements; compare between cohorts.
Time frame: from Day 3 to Day 7
count of recorded episodes outside recommended range.
Time frame: from Day 0 to discharge from the ICU
compare cohorts in participants who developed VAP.
Time frame: until discharge from ICU/hospital
compare cohorts.
University Medical Centre Ljubljana
Other
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
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