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..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3,260
Oral chlorhexidine gluconate oral rinse
Multifaceted education and audit/feedback.
Mount Sinai Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Intensive Care Unit (ICU) Mortality
All-cause mortality at time of ICU discharge
Time frame: 14 months
Infection-related ventilator-associated complications (IVACs)
Changes in IVACs rates between groups
Time frame: 14 months
Beck Oral Assessment Score (BOAS), Modified
Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction).
Time frame: 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.
Time frame: 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).
Time frame: 14 months
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Toronto Western Hospital
Toronto, Ontario, Canada