Ventilator-associated PneumoniaNCT05918172
Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care
An observational study of Ventilator-associated Pneumonia, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to compare manual (intermittent) versus automatic (continuous) endotracheal cuff pressure monitoring for the prevention of ventilator-associated pneumonia (VAP) in mechanically ventilated pediatric intensive care patients. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Ventilator-associated Pneumonia
- What is being tested?
- endotracheal cuff pressure manual measurement and endotracheal cuff pressure automatic measurement
- Type of treatment
- Medical device
- How many people
- 241 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 10 Jul 2024
- How long will I take part?
- 14 Days
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 1 month to 18 years who required at least 48 hours of mechanical ventilation in picu
Who may be able to join
- Children aged 1 month to 18 years
- Intubated and mechanically ventilated patients expected to require at least 48 hours of mechanical ventilation
- Eligibility assessed and enrollment completed within 24 hours of intubation and initiation of mechanical ventilation
Who cannot join
- Previous intubation within 14 days before enrollment
- Already receiving mechanical ventilation for more than 24 hours at the time of PICU admission or screening
- Expected duration of mechanical ventilation less than 48 hours
- Presence of tracheostomy
- Trauma-related tracheomalacia
- Stridor
Show all 12Show fewer
- Suspected or confirmed tracheal stenosis
- Suspected or confirmed immunodeficiency
- Current or previous malignancy
- Chronic pulmonary, cardiac, or other systemic disease
- Current use of immunosuppressive medications, including corticosteroids
- Declined consent / refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care; A Randomized Controlled Study
This study was designed to compare manual (intermittent) versus automatic (continuous) endotracheal cuff pressure monitoring for the prevention of ventilator-associated pneumonia (VAP) in mechanically ventilated pediatric intensive care patients. The study was based on the hypothesis that maintaining endotracheal cuff pressure within the optimal range may reduce the incidence of VAP.
Read the detailed description
Ventilator-associated pneumonia (VAP) is a major cause of morbidity and mortality in critically ill patients receiving mechanical ventilation. Microaspiration of bacteria-contaminated oropharyngeal and gastric secretions is considered one of the key mechanisms contributing to the development of VAP. Inadequate regulation of endotracheal tube cuff pressure, including both underinflation and overinflation, may increase the risk of microaspiration, VAP, and tracheal injury.
Intermittent manual monitoring and continuous automatic regulation of endotracheal tube cuff pressure have been used as preventive strategies against VAP. However, evidence regarding the comparative effectiveness of these two methods remains limited, particularly in the pediatric intensive care setting. This study was designed to evaluate the effectiveness of manual versus automatic cuff pressure monitoring in preventing VAP in mechanically ventilated pediatric intensive care patients.
This study was designed as a prospective, randomized, controlled, single-blind clinical trial. Eligible participants were pediatric patients aged 1 month to 18 years who required at least 48 hours of mechanical ventilation and were enrolled within 24 hours after intubation and initiation of mechanical ventilation. Participants were assigned in a 1:1 ratio to either the manual cuff pressure monitoring group or the automatic cuff pressure monitoring group according to a randomization table.
In the automatic monitoring group, endotracheal tube cuff pressure was continuously monitored and maintained at a target pressure of 20 cmH2O. In the manual monitoring group, cuff pressure was measured at 8-hour intervals, and any deviation from the target pressure was corrected at the time of assessment.
The primary objective was to compare the incidence of ventilator-associated pneumonia between the two study groups. VAP was diagnosed according to Centers for Disease Control and Prevention (CDC) criteria. Participants were also monitored for endotracheal tube-related complications, including airway injury and post-extubation upper airway findings such as stridor and suspected stenosis.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- endotracheal cuff pressure manual measurement, endotracheal cuff pressure automatic measurement
- 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.
endotracheal cuff pressure manual measurementDevice
The cuff pressure of the tracheal tube will be monitored every 8 hours in the manual group using a portable manometer. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. Before starting to work, PICU nurses will be given training in recognizing and preventing VAP and using cuff pressure measuring devices. The application period will continue from the day of intubation to extubation or a maximum of 14 days. Study data forms will be filled out by PICU nurses and monitored by physicians. The research group will periodically observe PICU personnel to verify adherence to the protocol. While patients are mechanically ventilated, VIP findings will be routinely screened at each daily visit.
endotracheal cuff pressure automatic measurementDevice
The cuff pressure of the tracheal tube will be monitored continuously using a pneumatic device in the automatic group. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients.
Before starting to work, PICU nurses will be given training in recognizing and preventing VAP and using cuff pressure measuring devices.
The application period will continue from the day of intubation to extubation or a maximum of 14 days Study data forms will be filled out by PICU nurses and monitored by physicians. The research group will periodically observe PICU personnel to verify adherence to the protocol. While patients are mechanically ventilated, VIP findings will be routinely screened at each daily visit.
| Study group | Role | What they receive |
|---|---|---|
| manual group | The cuff pressure of the tracheal tube will be monitored every 8 hours in the manual group using a portable manometer. The target endotracheal tube cuff pressure will be 20 cm H2O throughout the follow-up of the patients. Receives: Device: endotracheal cuff pressure manual measurement | |
| automatic group | The cuff pressure of the tracheal tube will be monitored continuously using a pneumatic device in the automatic group. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. Receives: Device: endotracheal cuff pressure automatic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of VIP incidences
The comparison of the VIP incidence in the patients followed in the manual and automatic cuff pressure measurement groups was determined as the primary outcome.
Measured: january 2022 - january 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Asik, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918172
- Sponsor's protocol ID
- 17334652306
- Status last verified
- Mar 2026
- First submitted
- 15 Jun 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marjanovic N, Boisson M, Asehnoune K, Foucrier A, Lasocki S, Ichai C, Leone M, Pottecher J, Lefrant JY, Falcon D, Veber B, Chabanne R, Drevet CM, Pili-Floury S, Dahyot-Fizelier C, Kerforne T, Seguin S, de Keizer J, Frasca D, Guenezan J, Mimoz O; AGATE Study Group. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study. Chest. 2021 Aug;160(2):499-508. doi: 10.1016/j.chest.2021.03.007. Epub 2021 Mar 13.
PubMed 33727034Lorente L, Lecuona M, Jimenez A, Lorenzo L, Roca I, Cabrera J, Llanos C, Mora ML. Continuous endotracheal tube cuff pressure control system protects against ventilator-associated pneumonia. Crit Care. 2014 Apr 21;18(2):R77. doi: 10.1186/cc13837.
PubMed 24751286Asik A, Duyu M, Ozdemir Daghan SH, Pehlivan P, Turkmen B, Sevinc NA, Tufekci Y, Ozyildirim B, Sametoglu SY, Bulut Y. Effectiveness of Continuous Automatic Endotracheal Cuff Pressure Monitoring in Preventing Ventilator-Associated Pneumonia in the Pediatric Intensive Care Unit: A Randomized Controlled Trial. Chest. 2026 Oct 10:S0012-3692(26)06801-7. doi: 10.1016/j.chest.2026.10.003. Online ahead of print.
PubMed 42858808
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care; A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05918172
- Acronym / sponsor ID
- 17334652306
- Conditions
- Ventilator-associated Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 26 Jun 2023 (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.
This study was designed to compare manual (intermittent) versus automatic (continuous) endotracheal cuff pressure monitoring for the prevention of ventilator-associated pneumonia (VAP) in mechanically ventilated pediatric intensive care patients. The study was based on the hypothesis that maintaining endotracheal cuff pressure within the optimal range may reduce the incidence of VAP.
Detailed description
Ventilator-associated pneumonia (VAP) is a major cause of morbidity and mortality in critically ill patients receiving mechanical ventilation. Microaspiration of bacteria-contaminated oropharyngeal and gastric secretions is considered one of the key mechanisms contributing to the development of VAP. Inadequate regulation of endotracheal tube cuff pressure, including both underinflation and overinflation, may increase the risk of microaspiration, VAP, and tracheal injury.
Intermittent manual monitoring and continuous automatic regulation of endotracheal tube cuff pressure have been used as preventive strategies against VAP. However, evidence regarding the comparative effectiveness of these two methods remains limited, particularly in the pediatric intensive care setting. This study was designed to evaluate the effectiveness of manual versus automatic cuff pressure monitoring in preventing VAP in mechanically ventilated pediatric intensive care patients.
This study was designed as a prospective, randomized, controlled, single-blind clinical trial. Eligible participants were pediatric patients aged 1 month to 18 years who required at least 48 hours of mechanical ventilation and were enrolled within 24 hours after intubation and initiation of mechanical ventilation. Participants were assigned in a 1:1 ratio to either the manual cuff pressure monitoring group or the automatic cuff pressure monitoring group according to a randomization table.
In the automatic monitoring group, endotracheal tube cuff pressure was continuously monitored and maintained at a target pressure of 20 cmH2O. In the manual monitoring group, cuff pressure was measured at 8-hour intervals, and any deviation from the target pressure was corrected at the time of assessment.
The primary objective was to compare the incidence of ventilator-associated pneumonia between the two study groups. VAP was diagnosed according to Centers for Disease Control and Prevention (CDC) criteria. Participants were also monitored for endotracheal tube-related complications, including airway injury and post-extubation upper airway findings such as stridor and suspected stenosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual group | – | Device: endotracheal cuff pressure manual measurementThe cuff pressure of the tracheal tube will be monitored every 8 hours in the manual group using a portable manometer. The target endotracheal tube cuff pressure will be 20 cm H2O throughout the follow-up of the patients. |
| automatic group | – | Device: endotracheal cuff pressure automatic measurementThe cuff pressure of the tracheal tube will be monitored continuously using a pneumatic device in the automatic group. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 1 month to 18 years who required at least 48 hours of mechanical ventilation in picu
Key inclusion criteria (3 listed)
- Children aged 1 month to 18 years
- Intubated and mechanically ventilated patients expected to require at least 48 hours of mechanical ventilation
- Eligibility assessed and enrollment completed within 24 hours of intubation and initiation of mechanical ventilation
Key exclusion criteria (12 listed)
- Previous intubation within 14 days before enrollment
- Already receiving mechanical ventilation for more than 24 hours at the time of PICU admission or screening
- Expected duration of mechanical ventilation less than 48 hours
- Presence of tracheostomy
- Trauma-related tracheomalacia
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 |
|---|---|---|
| endotracheal cuff pressure manual measurementThe cuff pressure of the tracheal tube will be monitored every 8 hours in the manual group using a portable manometer. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. Before starting to work, PICU nurses will be given training in recognizing and preventing VAP and using cuff pressure measuring devices. The application period will continue from the day of intubation to extubation or a maximum of 14 days. Study data forms will be filled out by PICU nurses and monitored by physicians. The research group will periodically observe PICU personnel to verify adherence to the protocol. While patients are mechanically ventilated, VIP findings will be routinely screened at each daily visit. | Device | manual group |
| endotracheal cuff pressure automatic measurementThe cuff pressure of the tracheal tube will be monitored continuously using a pneumatic device in the automatic group. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. Before starting to work, PICU nurses will be given training in recognizing and preventing VAP and using cuff pressure measuring devices. The application period will continue from the day of intubation to extubation or a maximum of 14 days Study data forms will be filled out by PICU nurses and monitored by physicians. The research group will periodically observe PICU personnel to verify adherence to the protocol. While patients are mechanically ventilated, VIP findings will be routinely screened at each daily visit. | Device | automatic group |
Primary outcome
Comparison of VIP incidences
Time frame: january 2022 - january 2024
The comparison of the VIP incidence in the patients followed in the manual and automatic cuff pressure measurement groups was determined as the primary outcome.
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 17 Mar 2026.
- Background: PubMed 33727034Marjanovic N, Boisson M, Asehnoune K, Foucrier A, Lasocki S, Ichai C, Leone M, Pottecher J, Lefrant JY, Falcon D, Veber B, Chabanne R, Drevet CM, Pili-Floury S, Dahyot-Fizelier C, Kerforne T, Seguin S, de Keizer J, Frasca D, Guenezan J, Mimoz O; AGATE Study Group. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study. Chest. 2021 Aug;160(2):499-508. doi: 10.1016/j.chest.2021.03.007. Epub 2021 Mar 13.
- Background: PubMed 24751286Lorente L, Lecuona M, Jimenez A, Lorenzo L, Roca I, Cabrera J, Llanos C, Mora ML. Continuous endotracheal tube cuff pressure control system protects against ventilator-associated pneumonia. Crit Care. 2014 Apr 21;18(2):R77. doi: 10.1186/cc13837.
- Derived from this study: PubMed 42858808Asik A, Duyu M, Ozdemir Daghan SH, Pehlivan P, Turkmen B, Sevinc NA, Tufekci Y, Ozyildirim B, Sametoglu SY, Bulut Y. Effectiveness of Continuous Automatic Endotracheal Cuff Pressure Monitoring in Preventing Ventilator-Associated Pneumonia in the Pediatric Intensive Care Unit: A Randomized Controlled Trial. Chest. 2026 Oct 10:S0012-3692(26)06801-7. doi: 10.1016/j.chest.2026.10.003. Online ahead of print.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 3 inclusion and 12 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 17 Mar 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 Turkey (Türkiye). 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?
Comparison of VIP incidences (time frame: january 2022 - january 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05918172, which also lists 3 linked publications.
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 17 Mar 2026.