Implementation and Evaluation of Revised Protocols for Oral Hygiene for Mechanically Ventilated Patients

• Ventilator-associated pneumonia [ Time Frame: Subjects will be assessed for this outcome from the date of randomization until discharge from the ICU (up to 30 days post-randomization) ] [ Designated as safety issue: No ]
  

• Frequency of documented oral care procedures [ Time Frame: The frequency of oral care procedures will be assessed daily from the date of randomization until discharge from the ICU (up to 30 days post-randomization) ] [ Designated as safety issue: No ]
  
• Oral Assessment Score [ Time Frame: Oral assessment scores will be assessed daily from the date of randomization until discharge from the ICU (up to 30 days post-randomization) ] [ Designated as safety issue: No ]
  
• Duration of ICU and hospital stay [ Time Frame: Subjects will be followed for these outcomes for the duration of their hospital stay up to 4 weeks after discharge from the ICU ] [ Designated as safety issue: No ]
  
• ICU and hospital mortality [ Time Frame: Subjects will be followed for these outcomes for the duration of their hospital stay up to 4 weeks after discharge from the ICU ] [ Designated as safety issue: No ]
  
• Antimicrobial utilization [ Time Frame: Utilization of antimicrobials will be assessed daily from the date of randomization until discharge from the ICU (up to 30 days post-randomization) ] [ Designated as safety issue: No ]
  
• Acquisition of antimicrobial resistant organisms [ Time Frame: Subjects will be followed for this outcome from the date of randomization until discharge from the ICU (up to 30 days post-randomization) ] [ Designated as safety issue: No ]
  

The primary objective of this study is to evaluate the effectiveness and feasibility of the implementation of revised standards of care for oral hygiene (SAGE Q-care q2 Oral Cleansing and Suctioning System with and without chlorhexidine gluconate) relative to the current routine standard of care in mechanically ventilated patients admitted to the adult Intensive Care Units in Alberta Health Services Calgary Zone. This pilot study will evaluate the feasibility of performing a larger definitive study. The primary assessment of effectiveness for the definitive study will be the proportion of patients who develop ventilator-associated pneumonia.

150 subjects will be randomly assigned using sealed opaque envelopes to one of three groups (Oral hygiene provided via the current local standard of care; Oral hygiene provided with a commercial packaged product (SAGE Q-care q2 Oral Cleansing and Suctioning System); Oral hygiene provided with a similar commercial packaged product with added chlorhexidine rinses twice daily (SAGE 24-Hour Suction Systems with chlorhexidine gluconate). Subjects will be provided the assigned method of oral hygiene by the bedside nurses from the time of ICU admission to the time of ICU discharge.

Key measurements include the acquisition of ventilator-associated pneumonia; the documented frequency of provision of oral care; the state of oral hygiene evaluated by recorded oral hygiene scores; duration of mechanical ventilation; ICU and hospital lengths of stay; ICU and hospital survival; Antimicrobial utilization; and the acquisition of antimicrobial resistant microbes.

For comparison of outcomes, means (with standard deviations) and medians (with interquartile ranges) will be reported for normally distributed and skewed variables respectively, and will be compared among the three groups using ANOVA or Kruskal-Wallis tests, respectively. Only the first episode of VAP in a patient will be evaluated. Given the small size of this pilot study, no interim or subgroup analyses are planned.