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

May 3, 2022 updated by: Craig M. Dale, University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada
        • Toronto General Hospital
      • Toronto, Ontario, Canada
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Does not meet inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Oral Chlorhexidine Mouth Rinse
Application of chlorhexidine gluconate mouth rinse per unit protocol.
Other: Chlorhexidine Mouth Rinse
Oral chlorhexidine gluconate oral rinse
Other Names:
  • Chlorhexidine
Experimental: De-Adoption of Oral Chlorhexidine Mouth Rinse
No application of chlorhexidine gluconate mouth rinse. Oral care bundle.
Other: Chlorhexidine Mouth Rinse De-Adoption
Multifaceted education and audit/feedback.
Other Names:
  • De-adopt chlorhexidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive Care Unit (ICU) Mortality
Time Frame: 14 months
All-cause mortality at time of ICU discharge
14 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

University Health Network, Toronto
Sunnybrook Health Sciences Centre
Unity Health Toronto
MOUNT SINAI HOSPITAL
Toronto General Hospital

Investigators

  • Principal Investigator: Brian Cuthbertson, MD FRCA, Sunnybrook Health Sciences Centre
  • Principal Investigator: Craig Dale, RN PhD, Sunnybrook Health Sciences Centre; University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0913

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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