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

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.

Study Overview

• Status: Completed
• Conditions: Oral Hygiene; Ventilator Associated Pneumonia
• Intervention / Treatment: Procedure: Standard Oral Hygiene; Procedure: SAGE Q-care q2; Procedure: SAGE Q-care q2 with Chlorhexidine

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y6J4
      • Alberta Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Oral Hygiene; 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.	Procedure: Standard Oral Hygiene; 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.
Active Comparator: SAGE Q-care q2; 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.	Procedure: SAGE Q-care q2; 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.
Active Comparator: SAGE Q-care q2 with Chlorhexidine; 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.	Procedure: SAGE Q-care q2 with Chlorhexidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ventilator-associated pneumonia	Subjects will be assessed for this outcome from the date of randomization until discharge from the ICU (up to 30 days post-randomization)

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of documented oral care procedures	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)
Oral Assessment Score	Oral assessment scores will be assessed daily from the date of randomization until discharge from the ICU (up to 30 days post-randomization)
Duration of ICU and hospital stay	Subjects will be followed for these outcomes for the duration of their hospital stay up to 4 weeks after discharge from the ICU
ICU and hospital mortality	Subjects will be followed for these outcomes for the duration of their hospital stay up to 4 weeks after discharge from the ICU
Antimicrobial utilization	Utilization of antimicrobials will be assessed daily from the date of randomization until discharge from the ICU (up to 30 days post-randomization)
Acquisition of antimicrobial resistant organisms	Subjects will be followed for this outcome from the date of randomization until discharge from the ICU (up to 30 days post-randomization)

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Sage Products, Inc.
• Investigators: Principal Investigator: Dan Zuege, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 19, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Intensive Care; Chlorhexidine; Oral Hygiene; Oral Care
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 23068