search
Back to results

Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER) (DEMETER)

Primary Purpose

Ventilator-associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endotracheal tubes not allowing SSD
Endotracheal tubes allowing SSD
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator-associated Pneumonia focused on measuring Ventilator-associated pneumonia, Subglottic-secretions drainage, Critically ill patients, Cost-utility analysis, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU André Vésale ,
  • CH Angoulème
  • CH Annecy Genevois
  • Centre Hospitalier Victor Dupouy
  • Centre Hospitalier Intercommunal des Portes de l'Oise
  • CHU Dijon
  • CHD Vendee
  • CH Docteur Schaffner
  • Centre Hospitalier François Quesnay
  • CHU marseilles, Hôpital Nord
  • CH de Montauban
  • CHU Nantes
  • Centre Hospitalier Régional d'Orléans
  • CHI Poissy Saint Germain
  • CHU Poitiers
  • Centre Hospitalier René Dubos
  • Hôpital Delafontaine
  • CH de Saint Nazaire
  • CHU de Strasbourg Hôpital de Hautepierre
  • CHU de Strasbourg Nouvel Hôpital Civil
  • CHU Tours, site Bretonneau
  • CHU Tours, site Trousseau
  • CHU Pointe à Pitre les Abymes
  • CHU La Réunion, site de Saint Pierre de la Réunion
  • CHU La Réunion, site de Saint Denis de la Réunion

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Period with endotracheal tubes not allowing SSD

Period with endotracheal tubes allowing SSD

Arm Description

During this period, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage

During this period, patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage

Outcomes

Primary Outcome Measures

Incremental cost-utility ratio
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation

Secondary Outcome Measures

Incremental cost-effectiveness ratio
Incremental cost to gain an additional patient free of adjudicated VAP
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
Incremental cost-effectiveness ratio
Incremental cost to gain an additional life-year
Budget impact analysis
Microbiologically-confirmed VAP incidence
Microbiologically-confirmed VAP density of incidence
Defined Daily Dose of antibiotics consumption
Ventilator-associated Conditions incidence
Ventilator-associated Conditions density of incidence
Infection related Ventilator-associated Conditions incidence
Duration of invasive mechanical ventilation
Ventilator-free days
ICU length of stay
Hospital length of stay
ICU mortality
90-days mortality
180-days mortality
1 year mortality
Post-extubation laryngo-tracheal dyspnea incidence

Full Information

First Posted
July 31, 2015
Last Updated
January 14, 2019
Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, URC Eco Ile de France, University Hospital, Tours
search

1. Study Identification

Unique Protocol Identification Number
NCT02515617
Brief Title
Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)
Acronym
DEMETER
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 5, 2015 (Actual)
Primary Completion Date
November 22, 2018 (Actual)
Study Completion Date
November 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, URC Eco Ile de France, University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Pneumonia
Keywords
Ventilator-associated pneumonia, Subglottic-secretions drainage, Critically ill patients, Cost-utility analysis, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2577 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Period with endotracheal tubes not allowing SSD
Arm Type
Active Comparator
Arm Description
During this period, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage
Arm Title
Period with endotracheal tubes allowing SSD
Arm Type
Experimental
Arm Description
During this period, patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage
Intervention Type
Device
Intervention Name(s)
Endotracheal tubes not allowing SSD
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Endotracheal tubes allowing SSD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incremental cost-utility ratio
Description
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation
Time Frame
1 year after ICU admission
Secondary Outcome Measure Information:
Title
Incremental cost-effectiveness ratio
Description
Incremental cost to gain an additional patient free of adjudicated VAP
Time Frame
1 year after ICU admission
Title
Incremental cost-utility ratio (subgroup analysis)
Description
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD in considering patients alive at the ICU discharge
Time Frame
1 year after ICU admission
Title
Incremental cost-effectiveness ratio
Description
Incremental cost to gain an additional life-year
Time Frame
1 year after ICU admission
Title
Budget impact analysis
Time Frame
5 years
Title
Microbiologically-confirmed VAP incidence
Time Frame
90 days after the start of invasive mechanical ventilation
Title
Microbiologically-confirmed VAP density of incidence
Time Frame
90 days after the start of invasive mechanical ventilation
Title
Defined Daily Dose of antibiotics consumption
Time Frame
Until discharge from ICU, an expected average of 12 days
Title
Ventilator-associated Conditions incidence
Time Frame
90 days after the start of invasive mechanical ventilation
Title
Ventilator-associated Conditions density of incidence
Time Frame
90 days after the start of invasive mechanical ventilation
Title
Infection related Ventilator-associated Conditions incidence
Time Frame
90 days after the start of invasive mechanical ventilation
Title
Duration of invasive mechanical ventilation
Time Frame
Until weaning of mechanical ventilation, an expected average of 10 days
Title
Ventilator-free days
Time Frame
90 days after the start of invasive mechanical ventilation
Title
ICU length of stay
Time Frame
Until discharge from ICU, an expected average of 12 days
Title
Hospital length of stay
Time Frame
Until discharge from hospital, an expected average of 20 days
Title
ICU mortality
Time Frame
Until discharge from ICU, an expected average of 12 days
Title
90-days mortality
Time Frame
90 days after ICU admission
Title
180-days mortality
Time Frame
180 days after ICU admission
Title
1 year mortality
Time Frame
1 year after ICU admission
Title
Post-extubation laryngo-tracheal dyspnea incidence
Time Frame
Until weaning of mechanical ventilation,, an expected average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude LACHERADE, MD
Organizational Affiliation
CHD VENDEE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU André Vésale ,
City
Montigny-le-Tilleul.
ZIP/Postal Code
6110
Country
Belgium
Facility Name
CH Angoulème
City
Angoulème
ZIP/Postal Code
16959
Country
France
Facility Name
CH Annecy Genevois
City
Annecy
ZIP/Postal Code
74374
Country
France
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Centre Hospitalier Intercommunal des Portes de l'Oise
City
Beaumont-sur-Oise
ZIP/Postal Code
95260
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHD Vendee
City
La roche sur yon
ZIP/Postal Code
85000
Country
France
Facility Name
CH Docteur Schaffner
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
Centre Hospitalier François Quesnay
City
Mantes la Jolie
ZIP/Postal Code
78200
Country
France
Facility Name
CHU marseilles, Hôpital Nord
City
Marseilels
ZIP/Postal Code
13000
Country
France
Facility Name
CH de Montauban
City
Montauban
ZIP/Postal Code
82013
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Hospitalier Régional d'Orléans
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
CHI Poissy Saint Germain
City
Poissy
ZIP/Postal Code
78600
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier René Dubos
City
Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
Hôpital Delafontaine
City
Saint Denis
ZIP/Postal Code
93200
Country
France
Facility Name
CH de Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44606
Country
France
Facility Name
CHU de Strasbourg Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU de Strasbourg Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU Tours, site Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU Tours, site Trousseau
City
Tours
Country
France
Facility Name
CHU Pointe à Pitre les Abymes
City
Pointe-à-Pitre
ZIP/Postal Code
97159
Country
Guadeloupe
Facility Name
CHU La Réunion, site de Saint Pierre de la Réunion
City
Saint Pierre
ZIP/Postal Code
97448
Country
Réunion
Facility Name
CHU La Réunion, site de Saint Denis de la Réunion
City
Saint-Denis
ZIP/Postal Code
97405
Country
Réunion

12. IPD Sharing Statement

Citations:
PubMed Identifier
21478738
Citation
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.
Results Reference
background
PubMed Identifier
20522796
Citation
Lacherade 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.
Results Reference
background
PubMed Identifier
25376073
Citation
Klompas 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.
Results Reference
background
PubMed Identifier
25871807
Citation
Branch-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.
Results Reference
background
PubMed Identifier
24321315
Citation
Loupec 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.
Results Reference
background

Learn more about this trial

Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)

We'll reach out to this number within 24 hrs