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

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ClinicalTrials.gov Identifier: NCT03382730
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Toronto General Hospital
University Health Network, Toronto
St. Michael's Hospital, Toronto
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Craig M. Dale, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Mortality Oral Health Dryness, Mouth Pain, Orofacial Other: Chlorhexidine Mouth Rinse Other: Chlorhexidine Mouth Rinse De-Adoption Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 4200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-centered stepped wedge cluster randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adoption

Arm Intervention/treatment
Oral Chlorhexidine Mouth Rinse
Application of chlorhexidine gluconate mouth rinse per unit protocol.
Other: Chlorhexidine Mouth Rinse
Oral chlorhexidine gluconate oral rinse
Other Name: 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 Name: De-adopt chlorhexidine




Primary Outcome Measures :
  1. Intensive Care Unit (ICU) Mortality [ Time Frame: 14 months ]
    All-cause mortality at time of ICU discharge


Secondary Outcome Measures :
  1. Infection-related ventilator-associated complications (IVACs) [ Time Frame: 14 months ]
    Changes in IVACs rates between groups

  2. 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).

  3. 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.

  4. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Does not meet inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382730


Contacts
Contact: Sarah Carbone, MSc 416-480-6100 ext 2389 sarah.carbone@sunnybrook.ca
Contact: Craig Dale, RN PhD 416-480-6100 ext 2387 craig.dale@sunnybrook.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Contact: Lisa Burry, PharmD       lburry@mtsinai.on.ca   
Principal Investigator: Lisa Burry, PharmD         
Principal Investigator: Michael Detsky, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Orla M Smith, RN PhD       Smitho@smh.ca   
Principal Investigator: Orla M Smith, RN PhD         
Principal Investigator: Jan O Friedrich, MD FRCP(C) DPhil         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Contact: Craig Dale, RN PhD       craig.dale@utoronto.ca   
Principal Investigator: Brian Cuthbertson, MB ChB MD FRCA         
Principal Investigator: Craig Dale, RN PhD         
Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Eddy Fan, MD PhD       eddy.fan@uhn.ca   
Principal Investigator: Eddy Fan, MD PhD         
Sub-Investigator: Clare Fielding, RN MN         
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Victoria McCredie, MD PhD       Victoria.McCredie@uhn.ca   
Principal Investigator: Victoria McCredie, MD PhD         
Sponsors and Collaborators
University of Toronto
Sunnybrook Health Sciences Centre
Toronto General Hospital
University Health Network, Toronto
St. Michael's Hospital, Toronto
Mount Sinai Hospital, New York
Investigators
Principal Investigator: Brian Cuthbertson, MD FRCA Sunnybrook Health Sciences Centre
Principal Investigator: Craig Dale, RN PhD Sunnybrook Health Sciences Centre; University of Toronto

Responsible Party: Craig M. Dale, Principal Investigator, University of Toronto
ClinicalTrials.gov Identifier: NCT03382730     History of Changes
Other Study ID Numbers: 0913
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Xerostomia
Mouth Diseases
Facial Pain
Salivary Gland Diseases
Stomatognathic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents