De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle (CHORAL)

University of Toronto

Status: Completed

Conditions: Mortality; Pain, Orofacial; Dryness, Mouth; Oral Health

Treatments: Other: Chlorhexidine Mouth Rinse; Other: Chlorhexidine Mouth Rinse De-Adoption

Study type: Interventional

Funder types: Other

Identifiers

NCT03382730

0913

Details and patient eligibility

About

The objective of the CHORAL study is to evaluate the de-adoption of oral chlorhexidine and the introduction of a bundle of oral care practices on selected outcomes in critically ill mechanically ventilated adults.

Full description

Infrequent or ineffective oral care can lead to mouth discomfort and lung infection for patients treated with ventilators (breathing machines) in intensive care units (ICUs). A commonly used mouthwash called chlorhexidine can reduce lung infection but most recent evidence shows it may increase the risk of death. In this study 6 participating intensive care units (ICUs) will de-adopt oral chlorhexidine and introduce a bundle of oral care practices using a multi-faceted educational tool kit. The investigators will measure changes in patient-oriented outcomes including mortality, ventilator-associated complications (VACs) and oral health status. A concurrent process evaluation will study how the intervention is delivered and received by patients and clinicians..

Enrollment: 3,260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who receive mechanical ventilation in the participating ICUs.

Exclusion criteria

• Does not meet inclusion criteria.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,260 participants in 2 patient groups

Oral Chlorhexidine Mouth Rinse

Other group

Description:

Application of chlorhexidine gluconate mouth rinse per unit protocol.

Treatment:

Other: Chlorhexidine Mouth Rinse

De-Adoption of Oral Chlorhexidine Mouth Rinse

Experimental group

Description:

No application of chlorhexidine gluconate mouth rinse. Oral care bundle.

Treatment:

Other: Chlorhexidine Mouth Rinse De-Adoption