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

NCT ID: NCT03382730

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-01-01

Brief Summary

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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

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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

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Mortality Oral Health Dryness, Mouth Pain, Orofacial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-centered stepped wedge cluster randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Oral Chlorhexidine Mouth Rinse

Application of chlorhexidine gluconate mouth rinse per unit protocol.

Group Type OTHER

Chlorhexidine Mouth Rinse

Intervention Type OTHER

Oral chlorhexidine gluconate oral rinse

De-Adoption of Oral Chlorhexidine Mouth Rinse

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

Group Type EXPERIMENTAL

Chlorhexidine Mouth Rinse De-Adoption

Intervention Type OTHER

Multifaceted education and audit/feedback.

Interventions

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Chlorhexidine Mouth Rinse

Oral chlorhexidine gluconate oral rinse

Intervention Type OTHER

Chlorhexidine Mouth Rinse De-Adoption

Multifaceted education and audit/feedback.

Intervention Type OTHER

Other Intervention Names

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Chlorhexidine De-adopt chlorhexidine

Eligibility Criteria

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Inclusion Criteria

* All patients who receive mechanical ventilation in the participating ICUs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Toronto General Hospital

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role collaborator

MOUNT SINAI HOSPITAL

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Craig M. Dale

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Cuthbertson, MD FRCA

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Craig Dale, RN PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre; University of Toronto

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 31651364 (View on PubMed)

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.

Reference Type RESULT
PMID: 34609548 (View on PubMed)

Other Identifiers

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0913

Identifier Type: -

Identifier Source: org_study_id

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