CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 175 enrolled
Drug / intervention
chlorhexidine gluconate oral rinse (0.12%) +1 moredrug
Likely dose
Chlorhexidine gluconate 0.12% oral rinseAI-extracted
Key inclusion· 2
  • Admitted to trauma ICU (TICU) and intubated with mechanical ventilation within 24–48 hours of admission
  • Comatose and intubated patients included as they represent highest risk for respiratory infection
Key exclusion· 12
  • Witnessed aspiration or confirmed post-obstructive pneumonia (e.g., advanced lung cancer)
  • Known hypersensitivity to chlorhexidine
  • Thrombocytopenia (platelet count <40) or INR >2, or other coagulopathy
  • Do not intubate order in place

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00123123
NCT00123123Phase 2Completed

Oral Health and Ventilator-associated Pneumonia

State University of New York at Buffalo·interventional·Posted Jul 22, 2005·Updated May 5, 2021

In Brief

A Phase 2 clinical trial evaluating chlorhexidine gluconate oral rinse (0.12%) and placebo for Pneumonia. Completed, enrolled 175 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2005
Enrollment StartMar 1, 2004
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.9 years ago

Interventions

chlorhexidine gluconate oral rinse (0.12%)drug

chlorhexidine gluconate oral rinse

placebodrug