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

Intensive Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583321
• Other study ID #: CHD 054-15
• Status: Completed
• Phase: N/A
• Start date: November 4, 2015
• Est. completion date: January 9, 2017

Study information

• Verified date: February 2019
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 9, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chlorhexidine
• Intensive Care

Intervention

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
• 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.

Locations

Country	Name	City	State
France	CHD Vendee	LA roche sur yon

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	Ministry of Health, France, University Hospital, Angers

Country where clinical trial is conducted

France, 

References & 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD		Day 3 of mechanical ventilation
Secondary	Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD		Day 3 of mechanical ventilation
Secondary	Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group.		Day 28 of mechanical ventilation
Secondary	Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD		Day 3 of mechanical ventilation
Secondary	Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period.		Day 28 of mechanical ventilation