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

University of Calgary

Status: Completed

Conditions: Ventilator Associated Pneumonia; Oral Hygiene

Treatments: Procedure: SAGE Q-care q2 with Chlorhexidine; Procedure: SAGE Q-care q2; Procedure: Standard Oral Hygiene

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01657396

23068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Standard Oral Hygiene

Active Comparator group

Description:

Oral hygiene provided by current local standard of care - minimum q2h mouthcare with a green Toothette swab dipped in sterile water, with excess liquid aspirated using a Yankauer suction. Brushing of teeth (if applicable) with a toothbrush and standard toothpaste q12h. Replacement of Yankauer suction device daily.

Treatment:

Procedure: Standard Oral Hygiene

SAGE Q-care q2

Active Comparator group

Description:

Oral hygiene provided with a commercial pre-packaged product (SAGE Q-care q2 Oral Cleansing and Suctioning System) - minimum q2h mouthcare using the supplied applicator swabs and covered Yankauer suction device using supplied Perox-A-Mint (a hydrogen peroxide based oral hygiene solution) alternating with alcohol-free mouthwash. Brushing of teeth (if applicable) with supplied applicator using Antiplaque solution (a cetylpyridinium based solution) q12h. Use of a new kit (which includes new covered Yankauer suction device) daily.

Treatment:

Procedure: SAGE Q-care q2

SAGE Q-care q2 with Chlorhexidine

Active Comparator group

Description:

Oral hygiene provided with a commercial pre-packaged product with chlorhexidine (SAGE Q-care Rx q2 Oral Cleansing and Suctioning System with CHG) - minimum q2h mouthcare using the supplied applicator swabs and covered Yankauer suction device using supplied Perox-A-Mint (a hydrogen peroxide based oral hygiene solution) alternating with alcohol-free mouthwash. Brushing of teeth (if applicable) with supplied applicator using chlorhexidine oral rinse (solution containing 0.12% chlorhexidine) q12h. Use of a new kit (which includes new covered Yankauer suction device) daily.

Treatment:

Procedure: SAGE Q-care q2 with Chlorhexidine