Intensive Care (ICU), Ventilator Associated Pneumonia ( VAP)
Conditions
Keywords
Intensive Care Units, Ventilators, Mechanical, Intubation, Intratracheal
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.
Detailed description
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.
Interventions
PROCEDUREContinous measurement of cuff pressure in endotracheal tube
Group1: Integrated continuous cuff pressure control
PROCEDUREIntermittent manual cuff pressure monitoring with manometer.
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.
Sponsors
University Medical Centre Ljubljana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ventilator-associated pneumonia (VAP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Median/average cuff pressure during ICU stay (cmH₂O) | from Day 3 to Day 7 | summarized per participant from recorded measurements; compare between cohorts. |
| Number of cuff-pressure events outside target range (<20 or >30 cmH₂O) | from Day 3 to Day 7 | count of recorded episodes outside recommended range. |
| Duration of mechanical ventilation among VAP-positive participants (hours) | from Day 0 to discharge from the ICU | compare cohorts in participants who developed VAP. |
| ICU and/or hospital length of stay (days) | until discharge from ICU/hospital | compare cohorts. |
Countries
Slovenia
Contacts
STUDY_DIRECTORPrimoz Gradisek
University Medical centre
Outcome results
None listed