Ventilator-associated PneumoniaDEMETERNCT02515617
Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)
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 25 sites in 4 countries.
Trial summary
In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to… 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
- 2,577 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 5 Nov 2015to 22 Nov 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
- 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 ICU 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
25 sites in 4 countries.
25 sites in 4 countries
France21 sites
CH Angoulème
Angoulème, 16959
CH Annecy Genevois
Annecy, 74374
Centre Hospitalier Victor Dupouy
Argenteuil, 95100
Centre Hospitalier Intercommunal des Portes de l'Oise
Beaumont-sur-Oise, 95260
CHU Dijon
Dijon, 21000
CHD Vendee
La Roche-sur-Yon, 85000
CH Docteur Schaffner
Lens, 62307
Centre Hospitalier François Quesnay
Mantes-la-Jolie, 78200
CHU marseilles, Hôpital Nord
Marseilels, 13000
CH de Montauban
Montauban, 82013
CHU Nantes
Nantes, 44000
Centre Hospitalier Régional d'Orléans
Orléans, 45067
CHI Poissy Saint Germain
Poissy, 78600
CHU Poitiers
Poitiers, 86021
Centre Hospitalier René Dubos
Pontoise, 95303
Hôpital Delafontaine
Saint-Denis, 93200
CH de Saint Nazaire
Saint-Nazaire, 44606
CHU de Strasbourg Hôpital de Hautepierre
Strasbourg, 67000
CHU de Strasbourg Nouvel Hôpital Civil
Strasbourg, 67000
CHU Tours, site Bretonneau
Tours, 37044
CHU Tours, site Trousseau
Tours
Reunion2 sites
CHU La Réunion, site de Saint Denis de la Réunion
Saint-Denis, 97405
CHU La Réunion, site de Saint Pierre de la Réunion
Saint-Pierre, 97448
About this study
Official title: Drainage of Subglottic Secretions and Prevention of Ventilator-associated Pneumonia in Intensive carE Units: Medico-Economic Study With a Randomized clusTer and crossovER Design: DEMETER Study
In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- Endotracheal tubes not allowing SSD, Endotracheal tubes allowing SSD
- Keywords
- Ventilator-associated pneumonia, Subglottic-secretions drainage, Critically ill patients, Cost-utility analysis, 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, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage Receives: Device: Endotracheal tubes not allowing SSD |
| Period with endotracheal tubes allowing SSD | Experimental | During this period, 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.
Incremental cost-utility ratio
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation
Measured: 1 year after ICU admission
Secondary outcomes (19)
Incremental cost-effectiveness ratio
Incremental cost to gain an additional patient free of adjudicated VAP
Measured: 1 year after ICU admission
Incremental cost-utility ratio (subgroup analysis)
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD in considering patients alive at the ICU discharge
Measured: 1 year after ICU admission
Incremental cost-effectiveness ratio
Incremental cost to gain an additional life-year
Measured: 1 year after ICU admission
Budget impact analysis
Measured: 5 years
Microbiologically-confirmed VAP incidence
Measured: 90 days after the start of invasive mechanical ventilation
Microbiologically-confirmed VAP density of incidence
Measured: 90 days after the start of invasive mechanical ventilation
Defined Daily Dose of antibiotics consumption
Measured: Until discharge from ICU, an expected average of 12 days
Ventilator-associated Conditions incidence
Measured: 90 days after the start of invasive mechanical ventilation
Ventilator-associated Conditions density of incidence
Measured: 90 days after the start of invasive mechanical ventilation
Infection related Ventilator-associated Conditions incidence
Measured: 90 days after the start of invasive mechanical ventilation
Duration of invasive mechanical ventilation
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Ventilator-free days
Measured: 90 days after the start of invasive mechanical ventilation
ICU length of stay
Measured: Until discharge from ICU, an expected average of 12 days
Hospital length of stay
Measured: Until discharge from hospital, an expected average of 20 days
ICU mortality
Measured: Until discharge from ICU, an expected average of 12 days
90-days mortality
Measured: 90 days after ICU admission
180-days mortality
Measured: 180 days after ICU admission
1 year mortality
Measured: 1 year after ICU admission
Post-extubation laryngo-tracheal dyspnea incidence
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 posted5 Aug 2015 (estimated)
- Study start5 Nov 2015
- Primary completion22 Nov 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, URC Eco Ile de France, University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Jean-Claude LACHERADE, MD, Principal investigator, CHD VENDEE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515617
- Sponsor's protocol ID
- CHD 045-14
- Acronym
- DEMETER
- Status last verified
- Jan 2018
- First submitted
- 31 Jul 2015
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. doi: 10.1097/CCM.0b013e318218a4d9.
PubMed 21478738Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.
PubMed 20522796Klompas M, Branson R, Eichenwald EC, Greene LR, Howell MD, Lee G, Magill SS, Maragakis LL, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S133-54. doi: 10.1017/s0899823x00193894. No abstract available.
PubMed 25376073Branch-Elliman W, Wright SB, Howell MD. Determining the Ideal Strategy for Ventilator-associated Pneumonia Prevention. Cost-Benefit Analysis. Am J Respir Crit Care Med. 2015 Jul 1;192(1):57-63. doi: 10.1164/rccm.201412-2316OC.
PubMed 25871807Loupec T, Petitpas F, Kalfon P, Mimoz O. Subglottic secretion drainage in prevention of ventilator-associated pneumonia: mind the gap between studies and reality. Crit Care. 2013 Dec 9;17(6):R286. doi: 10.1186/cc13149. No abstract available.
PubMed 24321315
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage of Subglottic Secretions and Prevention of Ventilator-associated Pneumonia in Intensive carE Units: Medico-Economic Study With a Randomized clusTer and crossovER Design: DEMETER Study
- ClinicalTrials.gov ID
- NCT02515617
- Acronym / sponsor ID
- DEMETER / CHD 045-14
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- Ventilator-associated pneumonia, Subglottic-secretions drainage, Critically ill patients, Cost-utility analysis, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,577 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- Ministry of Health, France, URC Eco Ile de France, University Hospital, Tours
- Study start
- 5 Nov 2015 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 5 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.
In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period with endotracheal tubes not allowing SSD | Active comparator | Device: Endotracheal tubes not allowing SSDDuring this period, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage |
| Period with endotracheal tubes allowing SSD | Experimental | Device: Endotracheal tubes allowing SSDDuring this period, 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 ICU 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
Incremental cost-utility ratio
Time frame: 1 year after ICU admission
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation
19 secondary outcomes
Incremental cost-effectiveness ratio
Time frame: 1 year after ICU admission
Incremental cost-utility ratio (subgroup analysis)
Time frame: 1 year after ICU admission
Incremental cost-effectiveness ratio
Time frame: 1 year after ICU admission
Budget impact analysis
Time frame: 5 years
Microbiologically-confirmed VAP incidence
Time frame: 90 days after the start of invasive mechanical ventilation
Microbiologically-confirmed VAP density of incidence
Time frame: 90 days after the start of invasive mechanical ventilation
Defined Daily Dose of antibiotics consumption
Time frame: Until discharge from ICU, an expected average of 12 days
Ventilator-associated Conditions incidence
Time frame: 90 days after the start of invasive mechanical ventilation
Ventilator-associated Conditions density of incidence
Time frame: 90 days after the start of invasive mechanical ventilation
Infection related Ventilator-associated Conditions incidence
Time frame: 90 days after the start of invasive mechanical ventilation
Duration of invasive mechanical ventilation
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Ventilator-free days
Time frame: 90 days after the start of invasive mechanical ventilation
ICU length of stay
Time frame: Until discharge from ICU, an expected average of 12 days
Hospital length of stay
Time frame: Until discharge from hospital, an expected average of 20 days
ICU mortality
Time frame: Until discharge from ICU, an expected average of 12 days
90-days mortality
Time frame: 90 days after ICU admission
180-days mortality
Time frame: 180 days after ICU admission
1 year mortality
Time frame: 1 year after ICU admission
Post-extubation laryngo-tracheal dyspnea incidence
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 15 Jan 2019.
- Background: PubMed 21478738Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. doi: 10.1097/CCM.0b013e318218a4d9.
- Background: PubMed 20522796Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.
- Background: PubMed 25376073Klompas M, Branson R, Eichenwald EC, Greene LR, Howell MD, Lee G, Magill SS, Maragakis LL, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S133-54. doi: 10.1017/s0899823x00193894. No abstract available.
- Background: PubMed 25871807Branch-Elliman W, Wright SB, Howell MD. Determining the Ideal Strategy for Ventilator-associated Pneumonia Prevention. Cost-Benefit Analysis. Am J Respir Crit Care Med. 2015 Jul 1;192(1):57-63. doi: 10.1164/rccm.201412-2316OC.
- Background: PubMed 24321315Loupec T, Petitpas F, Kalfon P, Mimoz O. Subglottic secretion drainage in prevention of ventilator-associated pneumonia: mind the gap between studies and reality. Crit Care. 2013 Dec 9;17(6):R286. doi: 10.1186/cc13149. No abstract available.
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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
25 sites in 4 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 25 sites in 4 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, Reunion, Belgium, Guadeloupe. 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?
Incremental cost-utility ratio (time frame: 1 year after ICU admission). 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 NCT02515617, which also lists 5 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 15 Jan 2019.