Mortality, Oral Health, Dryness, Mouth, Pain, Orofacial
Conditions
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.
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..
Interventions
Oral chlorhexidine gluconate oral rinse
OTHERChlorhexidine Mouth Rinse De-Adoption
Multifaceted education and audit/feedback.
Sponsors
Sunnybrook Health Sciences Centre
Toronto General Hospital
University Health Network, Toronto
Unity Health Toronto
MOUNT SINAI HOSPITAL
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Multi-centered stepped wedge cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients who receive mechanical ventilation in the participating ICUs.
Exclusion criteria
* Does not meet inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Unit (ICU) Mortality | 14 months | All-cause mortality at time of ICU discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection-related ventilator-associated complications (IVACs) | 14 months | Changes in IVACs rates between groups |
| Beck Oral Assessment Score (BOAS), Modified | 14 months | Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction). |
| Critical Care Pain Observational Tool (CPOT) | 14 months | Changes in oropharyngeal pain between groups. CPOT scores range from 0-8 with a score \>2 indicating presence of pain. |
| Oral Dryness - Numeric Rating Intensity Scale (NRS) | 14 months | Changes in oral dryness scores between groups. NRS scores range from 0 (no dryness) to 10 (severe dryness). |
Countries
Canada
Outcome results
None listed