NCT07423208

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Continous measurement of cuff pressure in endotracheal tube	Group1: Integrated continuous cuff pressure control
PROCEDURE	Intermittent 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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-01-07
• Completion: 2024-02-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Slovenia