Ventilator-associated PneumoniaNCT02583308
Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation
A study testing Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD in people with Ventilator-associated Pneumonia, run by Centre Hospitalier Departemental Vendee at 15 sites in 2 countries.
Trial summary
Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- What is being tested?
- Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 896 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 4 Nov 2015to 29 Nov 2017
- 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
- Age over 18 years
- Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
- Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
- Information delivered
Who cannot join
- Previous inclusion in the study
- Patients moribund at the Intensive Care Unit admission
- Pregnant, parturient or breast-feeding woman
- Patient hospitalized without consent and/or deprived of liberty by court's decision
- Patient under guardianship or curators
- Lack of social insurance
- Concomitant inclusion in a trial on VAP prevention
- Patient with no comprehension of the French language
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
France14 sites
CH Annecy Genevois
Annecy, 74374
Centre Hospitalier Victor Dupouy
Argenteuil, 95100
Centre Hospitalier Intercommunal des Portes de l'Oise
Beaumont-sur-Oise, 95260
Chd Vendee
La Roche-sur-Yon, 85000
CH Docteur Schaffner
Lens, 62307
CH de Montauban
Montauban, 82013
Centre Hospitalier Régional d'Orléans
Orléans, 45067
CHU Pointe-à-Pitre les Abymes
Pointe à Pitre, 97159
CHI Poissy Saint Germain
Poissy, 78600
Centre Hospitalier René Dubos
Pontoise, 95303
CHU La Réunion, site de Saint Denis de la Réunion
Saint-Denis (Réunion), 97405
CH de Saint Nazaire
Saint-Nazaire, 44606
CHU de Strasbourg Nouvel Hôpital Civil
Strasbourg, 67000
CHU Tours, site Bretonneau
Tours, 37044
About this study
Official title: Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)
Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.
This ancillary study will be performed in 14 centers participating to the DEMETER study
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- Endotracheal tubes not allowing SSD, Endotracheal tubes allowing SSD
- Keywords
- Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, Prevention
- 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 tubes not allowing SSDDevice
In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure
Endotracheal tubes allowing SSDDevice
In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure.
In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Period with endotracheal tubes not allowing SSD | Active comparator | During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Receives: Device: Endotracheal tubes not allowing SSD |
| Period with endotracheal tubes allowing SSD | Experimental | During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage Receives: Device: Endotracheal tubes allowing SSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Secondary outcomes (15)
Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start4 Nov 2015
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Jean-Claude LACHERADE, MD, Principal investigator, CHD VENDEE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583308
- Sponsor's protocol ID
- CHD 053-15
- Status last verified
- Mar 2021
- First submitted
- 20 Oct 2015
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29.
PubMed 14647884
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)
- ClinicalTrials.gov ID
- NCT02583308
- Acronym / sponsor ID
- CHD 053-15
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- Ministry of Health, France, University Hospital, Tours
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 22 Oct 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.
Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.
This ancillary study will be performed in 14 centers participating to the DEMETER study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period with endotracheal tubes not allowing SSD | Active comparator | Device: Endotracheal tubes not allowing SSDDuring this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions |
| Period with endotracheal tubes allowing SSD | Experimental | Device: Endotracheal tubes allowing SSDDuring this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
- Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
- Information delivered
Key exclusion criteria (8 listed)
- Previous inclusion in the study
- Patients moribund at the Intensive Care Unit admission
- Pregnant, parturient or breast-feeding woman
- Patient hospitalized without consent and/or deprived of liberty by court's decision
- Patient under guardianship or curators
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 tubes not allowing SSDIn each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure | Device | Period with endotracheal tubes not allowing SSD |
| Endotracheal tubes allowing SSDIn each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure. In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours. | Device | Period with endotracheal tubes allowing SSD |
Primary outcome
Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
15 secondary outcomes
Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 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 23 Mar 2021.
- Background: PubMed 14647884Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29.
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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.
Jean-Claude LACHERADE, MD principal investigator
CHD VENDEE
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD in people with Ventilator-associated Pneumonia, run by Centre Hospitalier Departemental Vendee at 15 sites in 2 countries.
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 8 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Belgium. 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?
Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group. (time frame: Until weaning of mechanical ventilation, an expected average of 10 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 NCT02583308, which also lists 1 linked publication.
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 23 Mar 2021.