Mechanical VentilationPAV-PROTECTNCT02514655
Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
A study of Mechanical Ventilation and Tracheal Intubation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Tracheal Intubation, Ventilator-acquired Pneumonia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 15 Aug 2015to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients aged ≥18 years
- Patients admitted in the ICU, mechanically ventilated and whose trachea was intubated by the oral route using tubes with catheter polyvinyl chloride "high-volume low pressure" and of standard shape tubes Intubation indication is decided by the physicians in charge according to the usual criteria of respiratory, neurological and /or hemodynamic failure
- With an expected duration of mechanical ventilation > 48 hours
Who cannot join
- Patients intubated by nasotracheal route
- Patients with tracheotomy before admission
- Patients intubated with a polyurethane balloon catheter or a polyvinyl chloride balloon catheter of conical shape
- Previously intubated patients for > 48 hours before their possible recruitment
- Moribund patients (terminal illness or care-limiting decision)
- Minors protected or incapacitated patients
Show all 13Show fewer
- Patients with recently diagnosed ENT cancer
- Patients with facial, thoracic, spinal or upper airway trauma
- Patients burned, intoxicated by fire fumes or caustic ingestion
- Patient pregnant or breastfeeding (or with known positive urine pregnancy test before inclusion)
- Patient intubated with a subglottic suction tube
- Unaffiliated patients to a social security
- Patients included in any other scientific study that may interfere with the outcome criteria of this study. This includes any other study on tracheal intubation or mechanical ventilation, if the use of the pressure control device may interfere with its endpoint.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Réanimation Médical et Toxicologique
Paris, 75010
Bruno MEGARBANE, MD, PhD, (+33)1 49 95 64 91, bruno.megarbane@aphp.fr
About this study
Official title: Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload.
The main objective of the investigators is to show that Nosten® device is more effective than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP occurrence.
Read the detailed description
Multicenter, controlled, prospective randomized open study with blinded assessment of the primary endpoint. Two groups are set up: one experimental group with the control of the cuff pressure by the Nosten® device versus one control group with the manual monitoring of the cuff pressure and inflation of the balloon.
Inclusion: All orotracheally intubated patients for an expected period > 48 hours will be selected. Inclusion will be decided using an algorithm adapted to each center to limit the number of inclusion per month without any biases.
The total number of required insclusion is 500, or 250 / group. This calculation is based on the assumption that a frequency of 25% of patients having at least one VAP in the reference strategy, ensuring a 80% power in the detection by Chi-2 test with a difference 10%. A bilateral risk of first species determined at 5% was considered.
- Conditions
- Mechanical Ventilation, Tracheal Intubation, Ventilator-acquired Pneumonia, Intubation -Related Tracheal Lesions
- Being tested
- Nosten® pressure control (it's not an antibiotic, but simple device), Manual pressure control
- Keywords
- Tracheal intubation, Cuff pressure, Ventilator-acquired pneumonia, Intensive care unit, Tracheal injuries
- 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.
Nosten® pressure control (it's not an antibiotic, but simple device)Device
One experimental group with the control of the cuff pressure by Nosten® device
Manual pressure controlOther
One control group with the manual monitoring of the cuff pressure and inflation of the balloon
| Study group | Role | What they receive |
|---|---|---|
| 1: Nosten® monitoring | Experimental | One experimental group with the control of the cuff pressure by Nosten® device Receives: Device: Nosten® pressure control (it's not an antibiotic, but simple device) |
| 2: Manual monitoring | Active comparator | One control group with the manual monitoring of the cuff pressure and inflation of the balloon Receives: Other: Manual pressure control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion)
To prove that the Nosten® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP.
Measured: up to 3 months
Secondary outcomes (5)
Reduction in the tracheobronchial bacterial colonization assessed using the bacteriological examination of the tracheal aspiration (as long as the patient is intubated during 3 months after inclusion)
using the bacteriological examination of the tracheal aspiration during the intensive care hospitalization
Measured: up to 3 months
Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)
before obtaining microbiological results needed to affirm the Ventilator-Acquired Pneumonia (VAP) according to the criteria of the American Thoracic Society (3 months)
Measured: up to 3 months
Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months)
Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)
Measured: up to 3 months
Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion)
Using Nosten® device
Measured: up to 3 months
Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months)
using the tracheal ischemia score [Touat L. Intensive Care Med 2014]
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study start15 Aug 2015
- Primary completion15 Aug 2015
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno MEGARBANE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514655
- Sponsor's protocol ID
- P111113
- Other IDs
- 2014-A00190-47
- Acronym
- PAV-PROTECT
- Status last verified
- Aug 2023
- First submitted
- 7 Jul 2015
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT02514655
- Acronym / sponsor ID
- PAV-PROTECT / P111113
- Conditions
- Mechanical Ventilation, Tracheal Intubation, Ventilator-acquired Pneumonia, Intubation -Related Tracheal Lesions
- Keywords
- Tracheal intubation, Cuff pressure, Ventilator-acquired pneumonia, Intensive care unit, Tracheal injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Aug 2015 (actual)
- Primary completion
- 15 Aug 2015 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Aug 2015 (estimated)
- 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.
Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload.
The main objective of the investigators is to show that Nosten® device is more effective than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP occurrence.
Detailed description
Multicenter, controlled, prospective randomized open study with blinded assessment of the primary endpoint. Two groups are set up: one experimental group with the control of the cuff pressure by the Nosten® device versus one control group with the manual monitoring of the cuff pressure and inflation of the balloon.
Inclusion: All orotracheally intubated patients for an expected period > 48 hours will be selected. Inclusion will be decided using an algorithm adapted to each center to limit the number of inclusion per month without any biases.
The total number of required insclusion is 500, or 250 / group. This calculation is based on the assumption that a frequency of 25% of patients having at least one VAP in the reference strategy, ensuring a 80% power in the detection by Chi-2 test with a difference 10%. A bilateral risk of first species determined at 5% was considered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Nosten® monitoring | Experimental | Device: Nosten® pressure control (it's not an antibiotic, but simple device)One experimental group with the control of the cuff pressure by Nosten® device |
| 2: Manual monitoring | Active comparator | Other: Manual pressure controlOne control group with the manual monitoring of the cuff pressure and inflation of the balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥18 years
- Patients admitted in the ICU, mechanically ventilated and whose trachea was intubated by the oral route using tubes with catheter polyvinyl chloride "high-volume low pressure" and of standard shape tubes Intubation indication is decided by the physicians in charge according to the usual criteria of respiratory, neurological and /or hemodynamic failure
- With an expected duration of mechanical ventilation > 48 hours
Key exclusion criteria (13 listed)
- Patients intubated by nasotracheal route
- Patients with tracheotomy before admission
- Patients intubated with a polyurethane balloon catheter or a polyvinyl chloride balloon catheter of conical shape
- Previously intubated patients for > 48 hours before their possible recruitment
- Moribund patients (terminal illness or care-limiting decision)
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 |
|---|---|---|
| Nosten® pressure control (it's not an antibiotic, but simple device)One experimental group with the control of the cuff pressure by Nosten® device | Device | 1: Nosten® monitoring |
| Manual pressure controlOne control group with the manual monitoring of the cuff pressure and inflation of the balloon | Other | 2: Manual monitoring |
Primary outcome
Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion)
Time frame: up to 3 months
To prove that the Nosten® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP.
5 secondary outcomes
Reduction in the tracheobronchial bacterial colonization assessed using the bacteriological examination of the tracheal aspiration (as long as the patient is intubated during 3 months after inclusion)
Time frame: up to 3 months
Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)
Time frame: up to 3 months
Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months)
Time frame: up to 3 months
Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion)
Time frame: up to 3 months
Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months)
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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.
Bruno MEGARBANE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mechanical Ventilation and Tracheal Intubation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 13 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno MEGARBANE, MD, PhD ((+33)1 49 95 64 91, bruno.megarbane@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion) (time frame: up to 3 months). 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 25 Jun 2025.