Ventilator Associated Pneumonia Clinical Trial
Official title:
Implementation and Evaluation of Revised Protocols for Oral Hygiene for Mechanically Ventilated Patients in Alberta Health Services Calgary Region - a Pilot Project.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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