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| ID | Type | Description | Link |
|---|---|---|---|
| 0120-119/2021/10 | Other Identifier | KME RS |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continous measurement of cuff pressure in endotracheal tube | Procedure | Group1: Integrated continuous cuff pressure control |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Median/average cuff pressure during ICU stay (cmH₂O) | summarized per participant from recorded measurements; compare between cohorts. | from Day 3 to Day 7 |
| Number of cuff-pressure events outside target range (<20 or >30 cmH₂O) |
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Inclusion Criteria:
Exclusion Criteria:
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Intensive care patients
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| Name | Affiliation | Role |
|---|---|---|
| Primoz Gradisek | University Medical centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre | Ljubljana | Slovenia |
De-identified participant-level data for primary and secondary outcomes (VAP status, cuff pressure metrics, key baseline variables, ventilation duration, ICU/hospital LOS), plus data dictionary.
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Available beginning [e.g., 6 months] after publication/primary results dissemination, for [e.g., 5 years].
Available upon reasonable request to the corresponding investigator, with a methodologically sound proposal and data use agreement.
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| 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. |
|
count of recorded episodes outside recommended range.
| from Day 3 to Day 7 |
| Duration of mechanical ventilation among VAP-positive participants (hours) | compare cohorts in participants who developed VAP. | from Day 0 to discharge from the ICU |
| ICU and/or hospital length of stay (days) | compare cohorts. | until discharge from ICU/hospital |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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