MortalityCHORALNCT03382730

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

A study testing Chlorhexidine Mouth Rinse and Chlorhexidine Mouth Rinse De-Adoption in people with Mortality and Oral Health, run by University of Toronto at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mortality, Oral Health, Dryness, Mouth
What is being tested?: Chlorhexidine Mouth Rinse and Chlorhexidine Mouth Rinse De-Adoption
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,260 participants
Where: 5 sitesCanada
Study dates: 1 Dec 2017to 1 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients who receive mechanical ventilation in the participating ICUs.

Who cannot join

Does not meet inclusion criteria.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Canada5 sites

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

Other trials in Canada

About this study

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

Read the 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
Being tested: Chlorhexidine Mouth Rinse, Chlorhexidine Mouth Rinse De-Adoption
Medical subject headings: Xerostomia, Facial Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chlorhexidine Mouth RinseOther
Also called Chlorhexidine
Oral chlorhexidine gluconate oral rinse
Chlorhexidine Mouth Rinse De-AdoptionOther
Also called De-adopt chlorhexidine
Multifaceted education and audit/feedback.

Study groups in NCT03382730
Study group	Role	What they receive
Oral Chlorhexidine Mouth Rinse	Other	Application of chlorhexidine gluconate mouth rinse per unit protocol. Receives: Other: Chlorhexidine Mouth Rinse
De-Adoption of Oral Chlorhexidine Mouth Rinse	Experimental	No application of chlorhexidine gluconate mouth rinse. Oral care bundle. Receives: Other: Chlorhexidine Mouth Rinse De-Adoption

What is being measured

The primary outcome is the main question the study is designed to answer.

Intensive Care Unit (ICU) Mortality
All-cause mortality at time of ICU discharge
Measured: 14 months

Secondary outcomes (4)

Infection-related ventilator-associated complications (IVACs)
Changes in IVACs rates between groups
Measured: 14 months
Beck Oral Assessment Score (BOAS), Modified
Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction).
Measured: 14 months
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.
Measured: 14 months
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).
Measured: 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20171 Jan 2020

First posted26 Dec 2017
Study start1 Dec 2017
Primary completion31 Jan 2019
Study completion1 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MortalityStudies of the same condition, open and under way.
More trials run by University of TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multi-centered stepped wedge cluster randomized controlled trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 3,260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03382730
Sponsor's protocol ID: 0913
Acronym: CHORAL
Status last verified: May 2022
First submitted: 19 Oct 2017
Last updated: 9 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31651364
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.
PubMed 34609548

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03382730
Acronym / sponsor ID: CHORAL / 0913
Conditions: Mortality, Oral Health, Dryness, Mouth, Pain, Orofacial
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,260 participants (actual)
Lead sponsor: University of TorontoUniversity, hospital or other
Collaborators: Sunnybrook Health Sciences Centre, Toronto General Hospital, University Health Network, Toronto, Unity Health Toronto, MOUNT SINAI HOSPITAL
Study start: 1 Dec 2017 (actual)
Primary completion: 31 Jan 2019 (actual)
Study completion: 1 Jan 2020 (actual)
First posted: 26 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Multi-centered stepped wedge cluster randomized controlled trial

Arm	Type	Receives
Oral Chlorhexidine Mouth Rinse	Other	Other: Chlorhexidine Mouth RinseApplication of chlorhexidine gluconate mouth rinse per unit protocol.
De-Adoption of Oral Chlorhexidine Mouth Rinse	Experimental	Other: Chlorhexidine Mouth Rinse De-AdoptionNo application of chlorhexidine gluconate mouth rinse. Oral care bundle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients who receive mechanical ventilation in the participating ICUs.

Key exclusion criteria (1 listed)

Does not meet inclusion criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chlorhexidine Mouth RinseAlso: ChlorhexidineOral chlorhexidine gluconate oral rinse	Other	Oral Chlorhexidine Mouth Rinse
Chlorhexidine Mouth Rinse De-AdoptionAlso: De-adopt chlorhexidineMultifaceted education and audit/feedback.	Other	De-Adoption of Oral Chlorhexidine Mouth Rinse

Primary outcome

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

4 secondary outcomes

Infection-related ventilator-associated complications (IVACs)
Time frame: 14 months
Beck Oral Assessment Score (BOAS), Modified
Time frame: 14 months
Critical Care Pain Observational Tool (CPOT)
Time frame: 14 months
Oral Dryness - Numeric Rating Intensity Scale (NRS)
Time frame: 14 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
Background: PubMed 31651364Dale 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 publication: PubMed 34609548Dale 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.
Individual participant dataSharing planned: No

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Chronic Kidney Disease and Hypertension
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Cuthbertson, MD FRCA principal investigator

Sunnybrook Health Sciences Centre

Craig Dale, RN PhD principal investigator

Sunnybrook Health Sciences Centre; University of Toronto

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Chlorhexidine Mouth Rinse and Chlorhexidine Mouth Rinse De-Adoption in people with Mortality and Oral Health, run by University of Toronto at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensive Care Unit (ICU) Mortality (time frame: 14 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03382730, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.