Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia

Not Applicable

Completed

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

• Registration Number: NCT02585180
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief Summary

Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.

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: 2015-10-22
• Study First Posted: 2015-10-23
• 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: 420

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 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 Drainage
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
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.	Until weaning of mechanical ventilation, an expected average of 10 days	For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the subglottic secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the subglottic secretions will be considered as the same than the one involved in VAP if these 2 same micro-organisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last subglottic secretions samples, if available, obtained before the VAP occurrence, will be taking account.

Secondary Outcome Measures

Name	Time	Method
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.	Until weaning of mechanical ventilation, an expected average of 10 days	For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the tracheal secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the tracheal secretions will be considered as the same than the one involved in VAP if these 2 same microorganisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last tracheal secretions samples, if available, obtained before the VAP occurrence will be taking account.
Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP	Until weaning of mechanical ventilation, an expected average of 10 days	Proportion of VAP for whom the probabilistic antibiotherapy used during the trial appeared to be empirically active
Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance	Until weaning of mechanical ventilation, an expected average of 10 days	Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the subglottic secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).
Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance	Until weaning of mechanical ventilation, an expected average of 10 days	Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the tracheal secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).

Trial Locations

Locations (15)

Chd Vendee; 🇫🇷 La roche sur yon, France

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

CH Annecy Genevois; 🇫🇷 Annecy, France

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

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

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

CH Docteur Schaffner; 🇫🇷 Lens, France

CH de Montauban; 🇫🇷 Montauban, France

CH de Saint Nazaire; 🇫🇷 Saint Nazaire, France

CHI Poissy Saint Germain; 🇫🇷 Poissy, France

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

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

CHU Tours, site Bretonneau; 🇫🇷 Tours, France

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

Centre Hospitalier René Dubos; 🇫🇷 Pontoise, France