Ventilator Associated Pneumonia ( VAP)ICPM-VAPNCT07423208
Integrated vs Manual Endotracheal Tube Cuff Pressure Monitoring and Ventilator-Associated Pneumonia
An observational study of Ventilator Associated Pneumonia ( VAP) and Intensive Care (ICU), run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP), Intensive Care (ICU)
- What is being tested?
- Continous measurement of cuff pressure in endotracheal tube and Intermittent manual cuff pressure monitoring with manometer.
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2021to 1 Feb 2024
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Continous measurement of cuff pressure in endotracheal tube, Intermittent manual cuff pressure monitoring with manometer.
- Keywords
- Intensive Care Units, Ventilators, Mechanical, Intubation, Intratracheal
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous measurement of cuff pressure in endotracheal tubeProcedure or surgery
Group1: Integrated continuous cuff pressure control
Intermittent manual cuff pressure monitoring with manometer.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Continous measurement of cuff pressure in endotracheal tube | |
| 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. Receives: Procedure: Intermittent manual cuff pressure monitoring with manometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (4)
Median/average cuff pressure during ICU stay (cmH₂O)
summarized per participant from recorded measurements; compare between cohorts.
Measured: 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.
Measured: from Day 3 to Day 7
Duration of mechanical ventilation among VAP-positive participants (hours)
compare cohorts in participants who developed VAP.
Measured: from Day 0 to discharge from the ICU
ICU and/or hospital length of stay (days)
compare cohorts.
Measured: until discharge from ICU/hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Dec 2021
- Primary completion7 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated Pneumonia ( VAP)Studies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Primoz Gradisek, Study director, University Medical centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423208
- Sponsor's protocol ID
- UMCLJ-ICU-VAP-CUFF-2021-01
- Other IDs
- 0120-119/2021/10
- Acronym
- ICPM-VAP
- Status last verified
- Nov 2021
- First submitted
- 10 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of Ventilator-Associated Pneumonia Between Integrated Mechanical Ventilator Cuff Pressure Monitoring and Manual Manometric Cuff Monitoring - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07423208
- Acronym / sponsor ID
- ICPM-VAP / UMCLJ-ICU-VAP-CUFF-2021-01
- Keywords
- Intensive Care Units, Ventilators, Mechanical, Intubation, Intratracheal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Integrated cuff pressure control | – | Procedure: Continous measurement of cuff pressure in endotracheal tubeDescription 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 | – | Procedure: Intermittent manual cuff pressure monitoring with manometer.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continous measurement of cuff pressure in endotracheal tubeGroup1: Integrated continuous cuff pressure control | Procedure or surgery | Cohort 1: Integrated cuff pressure control |
| 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. | Procedure or surgery | Cohort 2: Manual manometric cuff pressure monitoring |
Primary outcome
Incidence of ventilator-associated pneumonia (VAP)
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
4 secondary outcomes
Median/average cuff pressure during ICU stay (cmH₂O)
Time frame: from Day 3 to Day 7
Number of cuff-pressure events outside target range (<20 or >30 cmH₂O)
Time frame: from Day 3 to Day 7
Duration of mechanical ventilation among VAP-positive participants (hours)
Time frame: from Day 0 to discharge from the ICU
ICU and/or hospital length of stay (days)
Time frame: until discharge from ICU/hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Ventilator Associated Pneumonia ( VAP)
Not yet recruitingObservational study
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Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
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Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
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Active, not recruiting
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HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Primoz Gradisek study director
University Medical centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia ( VAP) and Intensive Care (ICU), run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator-associated pneumonia (VAP) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.