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

NCT02583321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Chlorhexidine
  • Intensive Care

Interventions

DEVICE

Endotracheal tubes not allowing SSD

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

DEVICE

Endotracheal tubes allowing SSD

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 & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Angers

    collaborator OTHER_GOV

  • Centre Hospitalier Departemental Vendee

    lead OTHER

Principal Investigators

  • Jean-Claude LACHERADE, MD · CHD VENDEE

  • Bertrand Diquet, Ph.D · University Hospital, Angers

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-04
Primary Completion
2017-01-05
Completion
2017-01-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583321 on ClinicalTrials.gov