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Strategies to Prevent Pneumonia (SToP Pneumonia)

Primary Purpose

Ventilator Associated Pneumonia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Toothbrushing only
Chlorhexidine only
Toothbrushing and Chlorhexidine
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring Pneumonia, Dental Health, Critical Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control group, usual care

Tooth brushing only

Chlorhexidine only

Toothbrushing and chlorhexidine

Arm Description

Usual care with no study interventions provided; no tooth brushing intervention and no chlorhexidine intervention. Usual care

Tooth brushing by study personnel three times per 24 hours (TID) without chlorhexidine application.

Oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID) without tooth brushing.

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2005
Last Updated
December 4, 2015
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00234598
Brief Title
Strategies to Prevent Pneumonia (SToP Pneumonia)
Official Title
Oral Care Intervention in Mechanically Ventilated Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
Pneumonia, Dental Health, Critical Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Munro, RN, ANP,PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States

12. IPD Sharing Statement

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Strategies to Prevent Pneumonia (SToP Pneumonia)

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