NCT03382730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

October 19, 2017

Last Update Submit

May 3, 2022

Conditions

MortalityOral HealthDryness, MouthPain, Orofacial

Outcome Measures

Primary Outcomes (1)

  • Intensive Care Unit (ICU) Mortality

    All-cause mortality at time of ICU discharge

    14 months

Secondary Outcomes (4)

  • Infection-related ventilator-associated complications (IVACs)

    14 months

  • Beck Oral Assessment Score (BOAS), Modified

    14 months

  • Critical Care Pain Observational Tool (CPOT)

    14 months

  • Oral Dryness - Numeric Rating Intensity Scale (NRS)

    14 months

Study Arms (2)

Oral Chlorhexidine Mouth Rinse

OTHER

Application of chlorhexidine gluconate mouth rinse per unit protocol.

Other: Chlorhexidine Mouth Rinse

De-Adoption of Oral Chlorhexidine Mouth Rinse

EXPERIMENTAL

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

Other: Chlorhexidine Mouth Rinse De-Adoption

Interventions

Chlorhexidine Mouth RinseOTHER

Oral chlorhexidine gluconate oral rinse

Also known as: Chlorhexidine
Oral Chlorhexidine Mouth Rinse
Chlorhexidine Mouth Rinse De-AdoptionOTHER

Multifaceted education and audit/feedback.

Also known as: De-adopt chlorhexidine
De-Adoption of Oral Chlorhexidine Mouth Rinse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Related Publications (2)

  • 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.

    PMID: 31651364BACKGROUND

  • 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.

    PMID: 34609548RESULT

MeSH Terms

Conditions

XerostomiaFacial Pain

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Brian Cuthbertson, MD FRCA

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Craig Dale, RN PhD

    Sunnybrook Health Sciences Centre; University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Multi-centered stepped wedge cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2017

First Posted

December 26, 2017

Study Start

December 1, 2017

Primary Completion

January 31, 2019

Study Completion

January 1, 2020

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(5)