Ventilation-associated PneumoniaAGATENCT02534974
Impact of the Addition of a Device Providing Continuous Pneumatic Regulation of Tube Cuff Pressure to an Overall Strategy Aimed at Preventing Ventilator-associated Pneumonia in the Severe Trauma Patient. A Multicentre, Randomised, Controlled Study.
A study testing NOSTEN in people with Ventilation-associated Pneumonia and Severe Trauma Patient, run by Poitiers University Hospital at 13 sites in France.
Trial summary
Ventilation-associated pneumonia is the main site of healthcare-associated infections in the severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia increases morbi-mortality, length of stay in intensive care and overall management costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation-associated Pneumonia, Severe Trauma Patient
- What is being tested?
- NOSTEN
- Type of treatment
- Medical device
- How many people
- 440 participants
- Where
- 13 sitesFrance
- Study dates
- 31 Jul 2015to 11 Apr 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patients having a severe trauma as defined by an Injury Severity Score (ISS) >15,
- Aged at least 18 years,
- Intubated for less than 15h,
- Necessitating recourse to mechanical ventilation for an expected period ≥ 48h,
- Participating in a social security scheme or benefiting from such a scheme by means of a third party.
Who cannot join
- Patient likely to die over the 48h following admission,
- Nasotracheal intubation,
- Patient intubated through a tracheal tube with subglottic secretion drainage
- Intubation carried out 24h or more after the trauma,
- Ventilation with tracheotomy,
- Refusal to participate in the research,
Show all 9Show fewer
- Contraindication to the head-up position,
- Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection,
- Persons benefiting from reinforced protection or persons deprived of freedom subsequent to a legal or administrative decision, minors under legal protection
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Sigismond LASOCKI
Angers, 49100
Sébastien PILI FLOURY
Besançon, 25030
Jean Michel CONSTANTIN
Clermont-Ferrand, 63100
Catherine PAUGAM
Clichy, 92110
Belaid BOUHEMAD
Dijon, 21000
Dominique FALCON
Grenoble, 38700
Marc LEONE
Marseille, 13915
Karim ASEHNOUNE
Nantes, 44000
Carole ICHAI
Nice, 06000
Jean Yves LEFRANT
Nîmes, 30900
Olivier MIMOZ
Poitiers, 86021
Benoit VEBER
Rouen, 76031
Julien POTTECHER
Strasbourg, 67098
About this study
Ventilation-associated pneumonia is the main site of healthcare-associated infections in the severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia increases morbi-mortality, length of stay in intensive care and overall management costs. As was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of nosocomial infections contracted in intensive care, success in this preventive endeavour depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation.
Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in maintaining tracheal balloon pressure than intermittent adjustments using a hand-held manometer. In one study, these devices clearly facilitated diminution of microaspiration of gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22 VAP/1000 days of mechanical ventilation; p = 0.005).
Read more
The investigators are putting forward the hypothesis that by adjoining a device providing continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°, oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP incidence by 50% in severely traumatised patients whose condition necessitates mechanical ventilation of an expected duration exceeding 48h.
Ours is the first large-scale study to evaluate the interest of an innovative technology bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care populations the most at risk, namely severe trauma patients, a population presently benefiting from the other recommended preventive measures.
- Being tested
- NOSTEN
- Keywords
- Critical care, Trauma patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOSTENDevice
Also called device providing continuous pneumatic regulation of tube cuff pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition
Measured: 28 days
Secondary outcomes (9)
Proportion of patients having developed VAP in ICU according to the ATS definition
Measured: max 60 days
Proportion of patients having developed early (≤ day 7) or late (> day 7) VAP in ICU according to the ATS definition
Measured: max 60 days
Time to first episode of VAP diagnosis according to the ATS definition
Measured: max 60 days
Proportion of patients developing ventilator-associated events (VAE) according to the CDC definition
Measured: max 60 days
Number of ventilator free days
Measured: max 60 days
Number of antibiotic free days
Measured: max 60 days
ICU length-of-stay
Measured: max 60 days
Proportion of patient who died during their ICU stay
Measured: max 60 days
Proportion of patients requiring corticosteroids or bronchodilators within 48 hours of tracheal extubation
Measured: max 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study start31 Jul 2015
- Primary completion15 Feb 2018
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilation-associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534974
- Sponsor's protocol ID
- AGATE
- Acronym
- AGATE
- Status last verified
- Apr 2018
- First submitted
- 28 Jul 2015
- Last updated
- 25 Apr 2019
- Results posted
- 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 33727034Marjanovic N, Frasca D, Asehnoune K, Paugam C, Lasocki S, Ichai C, Lefrant JY, Leone M, Dahyot-Fizelier C, Pottecher J, Falcon D, Veber B, Constantin JM, Seguin S, Guenezan J, Mimoz O; AGATE study group. Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol. BMJ Open. 2017 Aug 7;7(8):e017003. doi: 10.1136/bmjopen-2017-017003.
PubMed 28790042
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Addition of a Device Providing Continuous Pneumatic Regulation of Tube Cuff Pressure to an Overall Strategy Aimed at Preventing Ventilator-associated Pneumonia in the Severe Trauma Patient. A Multicentre, Randomised, Controlled Study.
- ClinicalTrials.gov ID
- NCT02534974
- Acronym / sponsor ID
- AGATE / AGATE
- Keywords
- Critical care, Trauma patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 28 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.
Ventilation-associated pneumonia is the main site of healthcare-associated infections in the severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia increases morbi-mortality, length of stay in intensive care and overall management costs. As was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of nosocomial infections contracted in intensive care, success in this preventive endeavour depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation.
Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in maintaining tracheal balloon pressure than intermittent adjustments using a hand-held manometer. In one study, these devices clearly facilitated diminution of microaspiration of gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22 VAP/1000 days of mechanical ventilation; p = 0.005).
The investigators are putting forward the hypothesis that by adjoining a device providing continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°, oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP incidence by 50% in severely traumatised patients whose condition necessitates mechanical ventilation of an expected duration exceeding 48h.
Ours is the first large-scale study to evaluate the interest of an innovative technology bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care populations the most at risk, namely severe trauma patients, a population presently benefiting from the other recommended preventive measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients having a severe trauma as defined by an Injury Severity Score (ISS) >15,
- Aged at least 18 years,
- Intubated for less than 15h,
- Necessitating recourse to mechanical ventilation for an expected period ≥ 48h,
- Participating in a social security scheme or benefiting from such a scheme by means of a third party.
Key exclusion criteria (9 listed)
- Patient likely to die over the 48h following admission,
- Nasotracheal intubation,
- Patient intubated through a tracheal tube with subglottic secretion drainage
- Intubation carried out 24h or more after the trauma,
- Ventilation with tracheotomy,
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 |
|---|---|---|
| NOSTENAlso: device providing continuous pneumatic regulation of tube cuff pressure | Device | – |
Primary outcome
Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition
Time frame: 28 days
9 secondary outcomes
Proportion of patients having developed VAP in ICU according to the ATS definition
Time frame: max 60 days
Proportion of patients having developed early (≤ day 7) or late (> day 7) VAP in ICU according to the ATS definition
Time frame: max 60 days
Time to first episode of VAP diagnosis according to the ATS definition
Time frame: max 60 days
Proportion of patients developing ventilator-associated events (VAE) according to the CDC definition
Time frame: max 60 days
Number of ventilator free days
Time frame: max 60 days
Number of antibiotic free days
Time frame: max 60 days
ICU length-of-stay
Time frame: max 60 days
Proportion of patient who died during their ICU stay
Time frame: max 60 days
Proportion of patients requiring corticosteroids or bronchodilators within 48 hours of tracheal extubation
Time frame: max 60 days
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 25 Apr 2019.
- Derived from this study: 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.
- Derived from this study: PubMed 28790042Marjanovic N, Frasca D, Asehnoune K, Paugam C, Lasocki S, Ichai C, Lefrant JY, Leone M, Dahyot-Fizelier C, Pottecher J, Falcon D, Veber B, Constantin JM, Seguin S, Guenezan J, Mimoz O; AGATE study group. Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol. BMJ Open. 2017 Aug 7;7(8):e017003. doi: 10.1136/bmjopen-2017-017003.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOSTEN in people with Ventilation-associated Pneumonia and Severe Trauma Patient, run by Poitiers University Hospital at 13 sites 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 5 inclusion and 9 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 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
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?
Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition (time frame: 28 days). 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 NCT02534974, which also lists 2 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 25 Apr 2019.