Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation

Study Overview
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Brief Summary
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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

Official Title
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Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: 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 (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

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 | 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 |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 enterobacteria 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 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 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 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 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 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 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 | 

 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