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

Not Applicable

Completed

• Conditions: Dryness, Mouth; Pain, Orofacial; Mortality; Oral Health
• Interventions: Other: Chlorhexidine Mouth Rinse; Other: Chlorhexidine Mouth Rinse De-Adoption

• Registration Number: NCT03382730
• Lead Sponsor: University of Toronto

Brief 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..

Study Timeline

• Study First Submitted: 2017-10-19
• Study Start: 2017-12-01
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-26
• Primary Completion: 2019-01-31
• Study Completion: 2020-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3260

Inclusion Criteria

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

Exclusion Criteria

• Does not meet inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Chlorhexidine Mouth Rinse	Chlorhexidine Mouth Rinse	Application of chlorhexidine gluconate mouth rinse per unit protocol.
De-Adoption of Oral Chlorhexidine Mouth Rinse	Chlorhexidine Mouth Rinse De-Adoption	No application of chlorhexidine gluconate mouth rinse. Oral care bundle.

Primary Outcome Measures

Name	Time	Method
Intensive Care Unit (ICU) Mortality	14 months	All-cause mortality at time of ICU discharge

Secondary Outcome Measures

Name	Time	Method
Infection-related ventilator-associated complications (IVACs)	14 months	Changes in IVACs rates between groups
Beck Oral Assessment Score (BOAS), Modified	14 months	Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction).
Critical Care Pain Observational Tool (CPOT)	14 months	Changes in oropharyngeal pain between groups. CPOT scores range from 0-8 with a score \>2 indicating presence of pain.
Oral Dryness - Numeric Rating Intensity Scale (NRS)	14 months	Changes in oral dryness scores between groups. NRS scores range from 0 (no dryness) to 10 (severe dryness).

Trial Locations

Locations (5)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada