Clinical trial NCT02515617: Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (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
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-associated Pneumonia
Keywords: Ventilator-associated pneumonia
Subglottic-secretions drainage
Critically ill patients
Cost-utility analysis
Prevention
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: URC Eco Ile de France
name: University Hospital, Tours
First posted: 2015-08-05
Enrollment: 2577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incremental cost-utility ratio
timeFrame: 1 year after ICU admission
Secondary outcomes:
measure: Incremental cost-effectiveness ratio
timeFrame: 1 year after ICU admission
measure: Incremental cost-utility ratio (subgroup analysis)
timeFrame: 1 year after ICU admission
measure: Incremental cost-effectiveness ratio
timeFrame: 1 year after ICU admission
measure: Budget impact analysis
timeFrame: 5 years
measure: Microbiologically-confirmed VAP incidence
timeFrame: 90 days after the start of invasive mechanical ventilation
measure: Microbiologically-confirmed VAP density of incidence
timeFrame: 90 days after the start of invasive mechanical ventilation
measure: Defined Daily Dose of antibiotics consumption
timeFrame: Until discharge from ICU, an expected average of 12 days
measure: Ventilator-associated Conditions incidence
timeFrame: 90 days after the start of invasive mechanical ventilation
measure: Ventilator-associated Conditions density of incidence
timeFrame: 90 days after the start of invasive mechanical ventilation
measure: Infection related Ventilator-associated Conditions incidence
timeFrame: 90 days after the start of invasive mechanical ventilation
measure: Duration of invasive mechanical ventilation
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Ventilator-free days
timeFrame: 90 days after the start of invasive mechanical ventilation
measure: ICU length of stay
timeFrame: Until discharge from ICU, an expected average of 12 days
measure: Hospital length of stay
timeFrame: Until discharge from hospital, an expected average of 20 days
measure: ICU mortality
timeFrame: Until discharge from ICU, an expected average of 12 days
measure: 90-days mortality
timeFrame: 90 days after ICU admission
measure: 180-days mortality
timeFrame: 180 days after ICU admission
measure: 1 year mortality
timeFrame: 1 year after ICU admission
measure: Post-extubation laryngo-tracheal dyspnea incidence
timeFrame: Until weaning of mechanical ventilation,, an expected average of 10 days
Other outcomes:
Locations:
city: Montigny-le-Tilleul.
country: Belgium
facility: CHU André Vésale ,
city: Angoulème
country: France
facility: CH Angoulème
city: Annecy
country: France
facility: CH Annecy Genevois
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Beaumont-sur-Oise
country: France
facility: Centre Hospitalier Intercommunal des Portes de l'Oise
city: Dijon
country: France
facility: CHU Dijon
city: La roche sur yon
country: France
facility: CHD Vendee
city: Lens
country: France
facility: CH Docteur Schaffner
city: Mantes la Jolie
country: France
facility: Centre Hospitalier François Quesnay
city: Marseilels
country: France
facility: CHU marseilles, Hôpital Nord
city: Montauban
country: France
facility: CH de Montauban
city: Nantes
country: France
facility: CHU Nantes
city: Orleans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Poissy
country: France
facility: CHI Poissy Saint Germain
city: Poitiers
country: France
facility: CHU Poitiers
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Saint Denis
country: France
facility: Hôpital Delafontaine
city: Saint Nazaire
country: France
facility: CH de Saint Nazaire
city: Strasbourg
country: France
facility: CHU de Strasbourg Hôpital de Hautepierre
city: Strasbourg
country: France
facility: CHU de Strasbourg Nouvel Hôpital Civil
city: Tours
country: France
facility: CHU Tours, site Bretonneau
city: Tours
country: France
facility: CHU Tours, site Trousseau
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe à Pitre les Abymes
city: Saint Pierre
country: Réunion
facility: CHU La Réunion, site de Saint Pierre de la Réunion
city: Saint-Denis
country: Réunion
facility: CHU La Réunion, site de Saint Denis de la Réunion
Study officials:
affiliation: CHD VENDEE
name: Jean-Claude LACHERADE, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.