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

NCT02583321 | Completed DMC

• 1 other identifier: CHD 054-15
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Chlorhexidine; Intensive Care

Keywords

chlorhexidine gluconate; oral care; mechanical ventilation; critically ill patients; tracheal secretions; subglottic secretions

Outcome Measures

Primary Outcomes (1)

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

  Day 3 of mechanical ventilation

Secondary Outcomes (4)

• 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

Study Arms (2)

Period with endotracheal tubes not allowing SSD

ACTIVE COMPARATOR

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

Period with endotracheal tubes allowing SSD

EXPERIMENTAL

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

Interventions

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

Period with endotracheal tubes not allowing SSD

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.

Period with endotracheal tubes allowing SSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient with no comprehension of the French language

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead
• Ministry of Health, France: collaborator
• University Hospital, Angers: collaborator

Study Sites (1)

CHD Vendee

La Roche-sur-Yon, 85170, France

Location

Related Publications (2)

• 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.

  PMID: 24663255 BACKGROUND

• 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.

  PMID: 24687313 BACKGROUND

Study Officials

• Jean-Claude LACHERADE, MD

  CHD VENDEE

  PRINCIPAL INVESTIGATOR

• Bertrand Diquet, Ph.D

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: November 4, 2015
• Primary Completion: January 5, 2017
• Study Completion: January 9, 2017
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

FR (1)