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

Primary Purpose

Mortality, Oral Health, Dryness, Mouth

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Chlorhexidine Mouth Rinse

Chlorhexidine Mouth Rinse De-Adoption

About this trial

This is an interventional prevention trial for Mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients who receive mechanical ventilation in the participating ICUs.

Exclusion Criteria:

Does not meet inclusion criteria.

Sites / Locations

Mount Sinai Hospital
St. Michael's Hospital
Sunnybrook Health Sciences Centre
Toronto General Hospital
Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Oral Chlorhexidine Mouth Rinse

De-Adoption of Oral Chlorhexidine Mouth Rinse

Arm Description

Application of chlorhexidine gluconate mouth rinse per unit protocol.

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

Outcomes

Primary Outcome Measures

Intensive Care Unit (ICU) Mortality

All-cause mortality at time of ICU discharge

Secondary Outcome Measures

Infection-related ventilator-associated complications (IVACs)

Changes in IVACs rates between groups

Beck Oral Assessment Score (BOAS), Modified

Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction).

Critical Care Pain Observational Tool (CPOT)

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)

Changes in oral dryness scores between groups. NRS scores range from 0 (no dryness) to 10 (severe dryness).

Full Information

NCT ID

NCT03382730

First Posted

October 19, 2017

Last Updated

May 3, 2022

Sponsor

University of Toronto

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03382730

Brief Title

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

Acronym

CHORAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

January 31, 2019 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Multi-centered stepped wedge cluster randomized controlled trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

3260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Chlorhexidine Mouth Rinse

Arm Type

Other

Arm Description

Application of chlorhexidine gluconate mouth rinse per unit protocol.

Arm Title

De-Adoption of Oral Chlorhexidine Mouth Rinse

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Chlorhexidine Mouth Rinse

Other Intervention Name(s)

Chlorhexidine

Intervention Description

Oral chlorhexidine gluconate oral rinse

Intervention Type

Other

Intervention Name(s)

Chlorhexidine Mouth Rinse De-Adoption

Other Intervention Name(s)

De-adopt chlorhexidine

Intervention Description

Multifaceted education and audit/feedback.

Primary Outcome Measure Information:

Title

Intensive Care Unit (ICU) Mortality

Description

All-cause mortality at time of ICU discharge

Time Frame

14 months

Secondary Outcome Measure Information:

Title

Infection-related ventilator-associated complications (IVACs)

Description

Changes in IVACs rates between groups

Time Frame

14 months

Title

Beck Oral Assessment Score (BOAS), Modified

Description

Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction).

Time Frame

14 months

Title

Critical Care Pain Observational Tool (CPOT)

Description

Changes in oropharyngeal pain between groups. CPOT scores range from 0-8 with a score >2 indicating presence of pain.

Time Frame

14 months

Title

Oral Dryness - Numeric Rating Intensity Scale (NRS)

Description

Changes in oral dryness scores between groups. NRS scores range from 0 (no dryness) to 10 (severe dryness).

Time Frame

14 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients who receive mechanical ventilation in the participating ICUs. Exclusion Criteria: Does not meet inclusion criteria.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Cuthbertson, MD FRCA

Organizational Affiliation

Sunnybrook Health Sciences Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Craig Dale, RN PhD

Organizational Affiliation

Sunnybrook Health Sciences Centre; University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Hospital

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Toronto Western Hospital

City

Toronto

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31651364

Citation

Dale CM, Rose L, Carbone S, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Pinto R, Quinonez CR, Sutherland S, Scales DC, Cuthbertson BH. Protocol for 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 mechanically ventilated critically ill patients: the CHORAL study. Trials. 2019 Oct 24;20(1):603. doi: 10.1186/s13063-019-3673-0.

Results Reference

background

PubMed Identifier

34609548

Citation

Dale CM, Rose L, Carbone S, Pinto R, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Scales DC, Cuthbertson BH. Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial. Intensive Care Med. 2021 Nov;47(11):1295-1302. doi: 10.1007/s00134-021-06475-2. Epub 2021 Oct 5.

Results Reference

result

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

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