Chlorhexidine, Intensive Care
Conditions
Keywords
chlorhexidine gluconate, oral care, mechanical ventilation, critically ill patients, tracheal secretions, subglottic secretions
Brief summary
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.
Interventions
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.
Sponsors
Ministry of Health, France
University Hospital, Angers
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years * Invasive mechanical ventilation (MV) delivered via an endotracheal tube and MV required more than 72 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 ICU 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 |
|---|---|
| Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD | Day 3 of mechanical ventilation |
Secondary
| Measure | 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 |
| 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 |
Countries
France
Outcome results
None listed