Strategies to Prevent Pneumonia (SToP Pneumonia)

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT00234598

Collaborator

National Institute of Nursing Research (NINR) (NIH)

547

Enrollment

Location

Arms

71.1

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator Associated Pneumonia	Procedure: Toothbrushing only Procedure: Chlorhexidine only Procedure: Toothbrushing and Chlorhexidine	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

547 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Oral Care Intervention in Mechanically Ventilated Adults

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

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.

Outcome Measures

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. [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.