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

Not Applicable

Completed

• Conditions: Intensive Care; Chlorhexidine
• Interventions: Device: Endotracheal tubes not allowing SSD; Device: Endotracheal tubes allowing SSD

• Registration Number: NCT02583321
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Study Start: 2015-11-04
• Primary Completion: 2017-01-05
• Study Completion: 2017-01-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period with endotracheal tubes not allowing SSD	Endotracheal tubes not allowing SSD	During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions
Period with endotracheal tubes allowing SSD	Endotracheal tubes allowing SSD	During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage

Primary Outcome Measures

Name	Time	Method
Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD	Day 3 of mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHD Vendee; 🇫🇷 LA roche sur yon, France