Clinical trial NCT02583321: Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate
Official title: Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate: an Ancillary Study of the DEMETER Trial (NCT02515617)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlorhexidine
Intensive Care
Keywords: chlorhexidine gluconate
oral care
mechanical ventilation
critically ill patients
tracheal secretions
subglottic secretions
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: University Hospital, Angers
First posted: 2015-10-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD
timeFrame: Day 3 of mechanical ventilation
Secondary outcomes:
measure: Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD
timeFrame: Day 3 of mechanical ventilation
measure: Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group.
timeFrame: Day 28 of mechanical ventilation
measure: Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD
timeFrame: Day 3 of mechanical ventilation
measure: Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period.
timeFrame: Day 28 of mechanical ventilation
Other outcomes:
Locations:
city: LA roche sur yon
country: France
facility: CHD Vendee
Study officials:
affiliation: CHD VENDEE
name: Jean-Claude LACHERADE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Bertrand Diquet, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.