Ventilator-associated Pneumonia
Conditions
Keywords
Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, 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
Interventions
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 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.
Sponsors
Ministry of Health, France
University Hospital, Tours
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 tracheal secretions according to the study group. | 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 |
| 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 |
Countries
Belgium, France
Outcome results
None listed