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

Ventilator-associated Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515617
• Other study ID #: CHD 045-14
• Status: Completed
• Phase: N/A
• Start date: November 5, 2015
• Est. completion date: November 22, 2018

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2577
• Est. completion date: November 22, 2018
• Est. primary completion date: November 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Device:
• Endotracheal tubes not allowing SSD
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 SSD
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.

Locations

Country	Name	City	State
Belgium	CHU André Vésale ,	Montigny-le-Tilleul.
France	CH Angoulème	Angoulème
France	CH Annecy Genevois	Annecy
France	Centre Hospitalier Victor Dupouy	Argenteuil
France	Centre Hospitalier Intercommunal des Portes de l'Oise	Beaumont-sur-Oise
France	CHU Dijon	Dijon
France	CHD Vendee	La roche sur yon
France	CH Docteur Schaffner	Lens
France	Centre Hospitalier François Quesnay	Mantes la Jolie
France	CHU marseilles, Hôpital Nord	Marseilels
France	CH de Montauban	Montauban
France	CHU Nantes	Nantes
France	Centre Hospitalier Régional d'Orléans	Orleans
France	CHI Poissy Saint Germain	Poissy
France	CHU Poitiers	Poitiers
France	Centre Hospitalier René Dubos	Pontoise
France	Hôpital Delafontaine	Saint Denis
France	CH de Saint Nazaire	Saint Nazaire
France	CHU de Strasbourg Hôpital de Hautepierre	Strasbourg
France	CHU de Strasbourg Nouvel Hôpital Civil	Strasbourg
France	CHU Tours, site Bretonneau	Tours
France	CHU Tours, site Trousseau	Tours
Guadeloupe	CHU Pointe à Pitre les Abymes	Pointe-à-Pitre
Réunion	CHU La Réunion, site de Saint Pierre de la Réunion	Saint Pierre
Réunion	CHU La Réunion, site de Saint Denis de la Réunion	Saint-Denis

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	Ministry of Health, France, University Hospital, Tours, URC Eco Ile de France

Countries where clinical trial is conducted

Belgium,  France,  Guadeloupe,  Réunion, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental cost-utility ratio	Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation	1 year after ICU admission
Secondary	Incremental cost-effectiveness ratio	Incremental cost to gain an additional patient free of adjudicated VAP	1 year after ICU admission
Secondary	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	1 year after ICU admission
Secondary	Incremental cost-effectiveness ratio	Incremental cost to gain an additional life-year	1 year after ICU admission
Secondary	Budget impact analysis		5 years
Secondary	Microbiologically-confirmed VAP incidence		90 days after the start of invasive mechanical ventilation
Secondary	Microbiologically-confirmed VAP density of incidence		90 days after the start of invasive mechanical ventilation
Secondary	Defined Daily Dose of antibiotics consumption		Until discharge from ICU, an expected average of 12 days
Secondary	Ventilator-associated Conditions incidence		90 days after the start of invasive mechanical ventilation
Secondary	Ventilator-associated Conditions density of incidence		90 days after the start of invasive mechanical ventilation
Secondary	Infection related Ventilator-associated Conditions incidence		90 days after the start of invasive mechanical ventilation
Secondary	Duration of invasive mechanical ventilation		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Ventilator-free days		90 days after the start of invasive mechanical ventilation
Secondary	ICU length of stay		Until discharge from ICU, an expected average of 12 days
Secondary	Hospital length of stay		Until discharge from hospital, an expected average of 20 days
Secondary	ICU mortality		Until discharge from ICU, an expected average of 12 days
Secondary	90-days mortality		90 days after ICU admission
Secondary	180-days mortality		180 days after ICU admission
Secondary	1 year mortality		1 year after ICU admission
Secondary	Post-extubation laryngo-tracheal dyspnea incidence		Until weaning of mechanical ventilation,, an expected average of 10 days