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

This study has been completed.
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Dr. Dan Zuege, University of Calgary
ClinicalTrials.gov Identifier:
NCT01657396
First received: July 25, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Ventilator Associated Pneumonia
Oral Hygiene
Procedure: Standard Oral Hygiene
Procedure: SAGE Q-care q2
Procedure: SAGE Q-care q2 with Chlorhexidine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Implementation and Evaluation of Revised Protocols for Oral Hygiene for Mechanically Ventilated Patients in Alberta Health Services Calgary Region - a Pilot Project.

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657396

Locations
Canada, Alberta
Alberta Health Services
Calgary, Alberta, Canada, T1Y6J4
Sponsors and Collaborators
University of Calgary
Sage Products, Inc.
Investigators
Principal Investigator: Dan Zuege, MD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Dan Zuege, Clinical Associate Professor of Medicine, University of Calgary
ClinicalTrials.gov Identifier: NCT01657396     History of Changes
Other Study ID Numbers: 23068
Study First Received: July 25, 2012
Last Updated: February 19, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Oral Care
Oral Hygiene
Intensive Care
Mechanical Ventilation
Chlorhexidine

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Chlorhexidine
Chlorhexidine gluconate
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014