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NCT Number: NCT02583321

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

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.

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Key information

Conditions

Chlorhexidine Intensive Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHD Vendee

La Roche-sur-Yon, 85170, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal tubes not allowing SSD

Device

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

Endotracheal tubes allowing SSD

Device

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.

Primary outcomes

  1. Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD

    Time frame: Day 3 of mechanical ventilation

Secondary outcomes

  1. Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD

    Time frame: Day 3 of mechanical ventilation

  2. Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group.

    Time frame: Day 28 of mechanical ventilation

  3. Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD

    Time frame: Day 3 of mechanical ventilation

  4. Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period.

    Time frame: Day 28 of mechanical ventilation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Collaborators

  • Ministry of Health, France
  • University Hospital, Angers

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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