Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate

Study Overview
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Brief Summary
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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.

Official Title
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Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate: an Ancillary Study of the DEMETER Trial (NCT02515617)

Conditions
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Chlorhexidine, Intensive Care

Intervention / Treatment
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* Device: Endotracheal tubes not allowing SSD
* Device: Endotracheal tubes allowing SSD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Period with endotracheal tubes not allowing SSD<br>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<br>* 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<br>|
| Experimental: Period with endotracheal tubes allowing SSD<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD |  | Day 3 of mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chlorhexidine gluconate, oral care, mechanical ventilation, critically ill patients, tracheal secretions, subglottic secretions