Integrated vs Manual Endotracheal Tube Cuff Pressure Monitoring and Ventilator-Associated Pneumonia (ICPM-VAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care (ICU); Ventilator Associated Pneumonia ( VAP)
• Intervention / Treatment: Procedure: Continous measurement of cuff pressure in endotracheal tube; Procedure: Intermittent manual cuff pressure monitoring with manometer.

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia
    • University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Intensive care patients

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Procedure: Continous measurement of cuff pressure in endotracheal tube; Group1: Integrated continuous cuff pressure control
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Study Director: Primoz Gradisek, University Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): January 7, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Intensive Care Units; Intubation, Intratracheal; Ventilators, Mechanical
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: UMCLJ-ICU-VAP-CUFF-2021-01; 0120-119/2021/10 (Other Identifier: KME RS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Available beginning [e.g., 6 months] after publication/primary results dissemination, for [e.g., 5 years].
• IPD Sharing Access Criteria: Available upon reasonable request to the corresponding investigator, with a methodologically sound proposal and data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No