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

NCT ID: NCT02515617

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2577 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-05
• Study Completion Date: 2018-11-22

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.

Conditions

Ventilator-associated Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Period with endotracheal tubes not allowing SSD

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

Group Type: ACTIVE_COMPARATOR

Endotracheal tubes not allowing SSD

Intervention Type: DEVICE

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

Period with endotracheal tubes allowing SSD

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

Group Type: EXPERIMENTAL

Endotracheal tubes allowing SSD

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

URC Eco Ile de France

UNKNOWN

Sponsor Role: collaborator

University Hospital, Tours

OTHER

Sponsor Role: collaborator

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Claude LACHERADE, MD

Role: PRINCIPAL_INVESTIGATOR

CHD VENDEE

Locations

CHU André Vésale ,

Montigny-le-Tilleul, , Belgium

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

Orléans, , 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, , France

CHU Pointe à Pitre les Abymes

Pointe-à-Pitre, , Guadeloupe

CHU La Réunion, site de Saint Denis de la Réunion

Saint-Denis, , Reunion

CHU La Réunion, site de Saint Pierre de la Réunion

Saint-Pierre, , Reunion

Countries

Belgium; France; Guadeloupe; Reunion

References

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.

Reference Type: BACKGROUND

PMID: 21478738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20522796 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25376073 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25871807 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24321315 (View on PubMed)

Other Identifiers

CHD 045-14

Identifier Type: -

Identifier Source: org_study_id