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

February 22, 2019 updated by: Centre Hospitalier Departemental Vendee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • LA roche sur yon, France, 85170
        • CHD Vendee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Period with 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
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
Experimental: Period with endotracheal tubes allowing SSD
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

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD
Time Frame: Day 3 of mechanical ventilation
Day 3 of mechanical ventilation
Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group.
Time Frame: Day 28 of mechanical ventilation
Day 28 of mechanical ventilation
Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD
Time Frame: Day 3 of mechanical ventilation
Day 3 of mechanical ventilation
Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period.
Time Frame: Day 28 of mechanical ventilation
Day 28 of mechanical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Collaborators

University Hospital, Angers
Ministry of Health, France

Investigators

  • Principal Investigator: Bertrand Diquet, Ph.D, University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2015

Primary Completion (Actual)

January 5, 2017

Study Completion (Actual)

January 9, 2017

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 054-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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