drugset / Trial / NCT00123123

Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

NCT00123123 ↗

RandomizedParallel-groupQuadruple-blindOther

Summary

Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.

Timeline

Start
2004-03
Primary completion
2007-11
Completion
2007-11

Outcome

Missed primary endpoint

registry Placebo vs Chlorhexidine/Placebo vs Chlorhexidine; p = 0.6750; ANOVA NCT00123123 ↗

paper While decontamination of the oral cavity with chlorhexidine did not reduce the total number of potential respiratory pathogens PMID 19765321 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine gluconate Other / unclassified 0.12 % Topical

Indications