Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation

Not Applicable

Completed

• Conditions: Ventilator-associated Pneumonia
• Interventions: Device: Endotracheal tubes not allowing SSD; Device: Endotracheal tubes allowing SSD

• Registration Number: NCT02583308
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Study Start: 2015-11-04
• Primary Completion: 2017-11-29
• Study Completion: 2017-11-29
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 896

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period with endotracheal tubes not allowing SSD	Endotracheal tubes not allowing SSD	During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions
Period with endotracheal tubes allowing SSD	Endotracheal tubes allowing SSD	During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.	Until weaning of mechanical ventilation, an expected average of 10 days

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.	Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.	Until weaning of mechanical ventilation, an expected average of 10 days

Trial Locations

Locations (15)

Centre Hospitalier Intercommunal des Portes de l'Oise; 🇫🇷 Beaumont-sur-Oise, France

CH de Montauban; 🇫🇷 Montauban, France

CHU de Strasbourg Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France

CHU André Vésale; 🇧🇪 Montigny-le-Tilleul., Belgium

CHU Pointe-à-Pitre les Abymes; 🇫🇷 Pointe-à-Pitre, France

Centre Hospitalier René Dubos; 🇫🇷 Pontoise, France

CHI Poissy Saint Germain; 🇫🇷 Poissy, France

Chd Vendee; 🇫🇷 La Roche sur Yon, France

CH de Saint Nazaire; 🇫🇷 Saint Nazaire, France

CHU Tours, site Bretonneau; 🇫🇷 Tours, France

CH Annecy Genevois; 🇫🇷 Annecy, France

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

CH Docteur Schaffner; 🇫🇷 Lens, France

Centre Hospitalier Régional d'Orléans; 🇫🇷 Orleans, France

CHU La Réunion, site de Saint Denis de la Réunion; 🇫🇷 Saint-Denis (Réunion), France