Clinical trial NCT02583308: Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation
Official title: Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-associated Pneumonia
Keywords: Ventilator-associated pneumonia
Surveillance
Subglottic-secretions
Critically ill patients
Prevention
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: University Hospital, Tours
First posted: 2015-10-22
Enrollment: 896
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: Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.

This ancillary study will be performed in 14 centers participating to the DEMETER study


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 Intensive Care Unit 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: Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
Secondary outcomes:
measure: Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
timeFrame: Until weaning of mechanical ventilation, an expected average of 10 days
measure: Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
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: 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: La Roche sur Yon
country: France
facility: Chd Vendee
city: Lens
country: France
facility: CH Docteur Schaffner
city: Montauban
country: France
facility: CH de Montauban
city: Orleans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Pointe-à-Pitre
country: France
facility: CHU Pointe-à-Pitre les Abymes
city: Poissy
country: France
facility: CHI Poissy Saint Germain
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Saint Nazaire
country: France
facility: CH de Saint Nazaire
city: Saint-Denis (Réunion)
country: France
facility: CHU La Réunion, site de Saint Denis de la Réunion
city: Strasbourg
country: France
facility: CHU de Strasbourg Nouvel Hôpital Civil
city: Tours
country: France
facility: CHU Tours, site Bretonneau
Study officials:
affiliation: CHD VENDEE
name: Jean-Claude LACHERADE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29.