NCT03382730

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

A Multi-centered Stepped Wedge Cluster Randomized Controlled Trial of the De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle for Ventilated Critically Ill Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,260 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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..

Conditions

• Mortality
• Oral Health
• Dryness, Mouth
• Pain, Orofacial

Interventions

Type	Name	Description
OTHER	Chlorhexidine Mouth Rinse	Oral chlorhexidine gluconate oral rinse
OTHER	Chlorhexidine Mouth Rinse De-Adoption	Multifaceted education and audit/feedback.

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-01-31
• Completion: 2020-01-01
• First posted: 2017-12-26
• Last updated: 2022-05-09

Locations

5 sites across 1 country: Canada