An interventional study of Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD in Chlorhexidine and Intensive Care, sponsored by Centre Hospitalier Departemental Vendee. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Prevention
Recent meta-analysis have suggested that the safety of oral care with chlorhexidine in patients under mechanical ventilation could be questionable. Whatever the hypothetical mechanisms involved (direct cellular toxicity, underdiagnosis of Ventilator-Associated Pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the cornerstone of this potential side effect of the routine oral care with chlorhexidine gluconate. The DEMETER study assessing the medico-economical impact of the subglottic secretions drainage study (NCT02515617) provides the opportunity to perform this proof of concept study (detection of chlorhexidine in tracheal secretions after routine oral care with chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion drainage on this potential detection of chlorhexidine.
This ancillary study will be performed in one of the centers participating to the DEMETER study.
Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
In the participating center, a bundle of Ventilator-Associated Pneumonia (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 the 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.
Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD
Time frame: Day 3 of mechanical ventilation
Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD
Time frame: Day 3 of mechanical ventilation
Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group.
Time frame: Day 28 of mechanical ventilation
Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD
Time frame: Day 3 of mechanical ventilation
Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period.
Time frame: Day 28 of mechanical ventilation
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Departemental Vendee