Strategies to Prevent Pneumonia (SToP Pneumonia)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Care Intervention in Mechanically Ventilated Adults

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Procedure: Toothbrushing only
* Procedure: Chlorhexidine only
* Procedure: Toothbrushing and Chlorhexidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Dental Health, Critical Care