Strategies to Prevent Pneumonia (SToP Pneumonia)

December 4, 2015 updated by: Virginia Commonwealth University

Oral Care Intervention in Mechanically Ventilated Adults

This study tests whether special oral care provided by nurses to critically ill patients who are on a breathing machine (mechanical ventilator) can help to reduce the build-up of dental plaque on the teeth and reduce the risk of pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pneumonia is the leading cause of death from hospital-acquired infections. Intubation and mechanical ventilation greatly increase the risk of bacterial ventilator associated pneumonia. Growth of potentially pathogenic bacteria in dental plaque of critically ill patients provides a nidus of infection for microorganisms that have been shown to be responsible for the development of Ventilator Associated Pneumonia. Since these organisms are concentrated in dental plaque, removal of organisms from the oral cavity by oral care interventions is a theoretically attractive method to reduce the risk of development of Ventilator Associated Pneumonia. However, evidence-based protocols for oral care of mechanically ventilated patients are not available. Results of the study have the potential to improve nursing care, and to positively affect patient well-being, morbidity, mortality, and health care costs.

Study Type

Interventional

Enrollment (Actual)

547

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 18 years or older, admitted to one of four intensive care units at the study hospital, breathing tube in place, and on a breathing machine (mechanical ventilator)

Exclusion Criteria:

  • Breathing tube in place for more than 24 hours prior to entry into the study, absence of teeth, or a medical diagnosis of pneumonia when the breathing tube is put in.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group, usual care
Usual care with no study interventions provided; no tooth brushing intervention and no chlorhexidine intervention. Usual care
Active Comparator: Tooth brushing only
Tooth brushing by study personnel three times per 24 hours (TID) without chlorhexidine application.
Procedure: Toothbrushing only
Toothbrushing three times per 24 hours without chlorhexidine
Active Comparator: Chlorhexidine only
Oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID) without tooth brushing.
Procedure: Chlorhexidine only
Chlorhexidine oral rinse twice per 24 hours without toothbrushing
Active Comparator: Toothbrushing and chlorhexidine
Tooth brushing by study personnel three times per 24 hours (TID) and oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID)
Procedure: Toothbrushing and Chlorhexidine
Toothbrushing three times per 24 hours plus chlorhexidine twice per 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of build-up of dental plaque on the teeth and reduced risk of pneumonia in critical care patients, as a result of special oral care provided by nurses.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Cindy Munro, RN, ANP,PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 7, 2005

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCU1006
  • R01NR007652 (U.S. NIH Grant/Contract)
  • R01 NR07652 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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