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

Study Overview
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Brief Summary
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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

Official Title
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Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)

Conditions
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Ventilator-associated Pneumonia

Intervention / Treatment
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* Device: Endotracheal tubes not allowing SSD
* Device: Endotracheal tubes allowing SSD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Period with endotracheal tubes not allowing SSD<br>During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage | Device: Endotracheal tubes not allowing SSD<br>* 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<br>|
| Experimental: Period with endotracheal tubes allowing SSD<br>During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage | Device: Endotracheal tubes allowing SSD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance. | 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. | Until weaning of mechanical ventilation, an expected average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance. | 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. | Until weaning of mechanical ventilation, an expected average of 10 days | 
| Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP | Proportion of VAP for whom the probabilistic antibiotherapy used during the trial appeared to be empirically active | Until weaning of mechanical ventilation, an expected average of 10 days | 
| Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance | 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). | Until weaning of mechanical ventilation, an expected average of 10 days | 
| Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance | 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). | Until weaning of mechanical ventilation, an expected average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, Prevention