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

NCT01657396 | Completed

• 1 other identifier: 23068
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Oral Hygiene

Keywords

Oral Care; Oral Hygiene; Intensive Care; Mechanical Ventilation; Chlorhexidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

Study Arms (3)

Standard Oral Hygiene

ACTIVE COMPARATOR

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

SAGE Q-care q2

ACTIVE COMPARATOR

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

SAGE Q-care q2 with Chlorhexidine

ACTIVE COMPARATOR

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

Interventions

Standard Oral Hygiene PROCEDURE

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.

Standard Oral Hygiene

SAGE Q-care q2 PROCEDURE

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.

SAGE Q-care q2

SAGE Q-care q2 with Chlorhexidine PROCEDURE

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.

SAGE Q-care q2 with Chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• Sage Products, Inc.: collaborator

Study Sites (1)

Alberta Health Services

Calgary, Alberta, T1Y6J4, Canada

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dan Zuege, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Medicine

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: August 6, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

CA (1)