Ventilator-associated Pneumonia
Conditions
Keywords
Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, Prevention
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
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 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 | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Belgium, France
Outcome results
None listed