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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
| Toronto General Hospital | OTHER |
| University Health Network, Toronto | OTHER |
| Unity Health Toronto |
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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Chlorhexidine Mouth Rinse | Other | Application of chlorhexidine gluconate mouth rinse per unit protocol. |
|
| De-Adoption of Oral Chlorhexidine Mouth Rinse | Experimental | No application of chlorhexidine gluconate mouth rinse. Oral care bundle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Mouth Rinse | Other | Oral chlorhexidine gluconate oral rinse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit (ICU) Mortality | All-cause mortality at time of ICU discharge | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infection-related ventilator-associated complications (IVACs) | Changes in IVACs rates between groups | 14 months |
| Beck Oral Assessment Score (BOAS), Modified | Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Cuthbertson, MD FRCA | Sunnybrook Health Sciences Centre | Principal Investigator |
| Craig Dale, RN PhD | Sunnybrook Health Sciences Centre; University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | Canada | |||
| St. Michael's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31651364 | Background | 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. | |
| 34609548 |
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| OTHER |
| MOUNT SINAI HOSPITAL | OTHER |
Multi-centered stepped wedge cluster randomized controlled trial
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| Chlorhexidine Mouth Rinse De-Adoption | Other | Multifaceted education and audit/feedback. |
|
|
| 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. | 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). | 14 months |
| Toronto |
| Ontario |
| Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| Toronto Western Hospital | Toronto | Ontario | Canada |
| Result |
| 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. |
| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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