Clinical trial NCT01657396: Implementation and Evaluation of Revised Protocols for Oral Hygiene for Mechanically Ventilated Patients
Official title: Implementation and Evaluation of Revised Protocols for Oral Hygiene for Mechanically Ventilated Patients in Alberta Health Services Calgary Region - a Pilot Project.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Oral Hygiene
Keywords: Oral Care
Oral Hygiene
Intensive Care
Mechanical Ventilation
Chlorhexidine
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Sage Products, Inc.
First posted: 2012-08-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults (at least 18 years old)
* Newly admitted to the intensive care unit
* Receiving invasive mechanical ventilation via a endotracheal tube or tracheostomy

Exclusion Criteria:

* Under the age of 18
* Documented allergy to chlorhexidine
* Contraindication to the provision of standard oral hygiene (eg. recent oropharyngeal surgery or a defined surgical limitation to oral care)

Primary outcomes:
measure: Ventilator-associated pneumonia
timeFrame: Subjects will be assessed for this outcome from the date of randomization until discharge from the ICU (up to 30 days post-randomization)
Secondary outcomes:
measure: Frequency of documented oral care procedures
timeFrame: 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)
measure: Oral Assessment Score
timeFrame: Oral assessment scores will be assessed daily from the date of randomization until discharge from the ICU (up to 30 days post-randomization)
measure: Duration of ICU and hospital stay
timeFrame: Subjects will be followed for these outcomes for the duration of their hospital stay up to 4 weeks after discharge from the ICU
measure: ICU and hospital mortality
timeFrame: Subjects will be followed for these outcomes for the duration of their hospital stay up to 4 weeks after discharge from the ICU
measure: Antimicrobial utilization
timeFrame: Utilization of antimicrobials will be assessed daily from the date of randomization until discharge from the ICU (up to 30 days post-randomization)
measure: Acquisition of antimicrobial resistant organisms
timeFrame: Subjects will be followed for this outcome from the date of randomization until discharge from the ICU (up to 30 days post-randomization)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services
state: Alberta
Study officials:
affiliation: University of Calgary
name: Dan Zuege, MD
role: PRINCIPAL_INVESTIGATOR
References: