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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| University Hospital, Angers | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period with endotracheal tubes not allowing SSD | Active Comparator | During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions |
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| Period with endotracheal tubes allowing SSD | Experimental | During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal tubes not allowing SSD | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD | Day 3 of mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD | Day 3 of mechanical ventilation | |
| Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group. | Day 28 of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Claude LACHERADE, MD | CHD VENDEE | Principal Investigator |
| Bertrand Diquet, Ph.D | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHD Vendee | La Roche-sur-Yon | 85170 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24663255 | Background | Klompas M, Speck K, Howell MD, Greene LR, Berenholtz SM. Reappraisal of routine oral care with chlorhexidine gluconate for patients receiving mechanical ventilation: systematic review and meta-analysis. JAMA Intern Med. 2014 May;174(5):751-61. doi: 10.1001/jamainternmed.2014.359. | |
| 24687313 | Background | Price R, MacLennan G, Glen J; SuDDICU Collaboration. Selective digestive or oropharyngeal decontamination and topical oropharyngeal chlorhexidine for prevention of death in general intensive care: systematic review and network meta-analysis. BMJ. 2014 Mar 31;348:g2197. doi: 10.1136/bmj.g2197. |
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| Endotracheal tubes allowing SSD | Device | 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. |
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| Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD | Day 3 of mechanical ventilation |
| Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period. | Day 28 of mechanical ventilation |