Strategies To Prevent Pneumonia 2 (SToPP2)
Ventilator-associated pneumonia is a serious complication in mechanically ventilated critically ill patients. The intervention tested in this project (swabbing the mouth with chlorhexidine before the endotracheal tube is inserted) could reduce the risk of ventilator-associated pneumonia.
Nosocomial (Hospital-Acquired) Infections
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Oral Care Intervention in Mechanically Ventilated Adults|
- Development of VAP (Clinical Pulmonary Infection Score) [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
- endotracheal tube colonization [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- serum cytokines [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
- serum procalcitonin [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
|Active Comparator: 2||
No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Ventilator-associated pneumonia (VAP) is an acute care complication with high morbidity and mortality, which is costly in length of stay and resources used. Application of chlorhexidine (CHX) to the mouths of critically ill adults after intubation reduces risk of VAP. During intubation, organisms may be dragged by the tube from the contaminated mouth to the sterile lung, and the endotracheal tube (ET) provides a pathway for direct entry of bacteria from the mouth to the lower respiratory tract. However, procedures to decontaminate the mouth before intubation are not routine and little is known about the effects of pre-intubation CHX in critically ill patients. Thus, this project focuses on evaluating the benefit of adding a pre-intubation CHX dose to the known benefit of post-intubation CHX to reduce the risk of VAP. In order to examine the effect of pre-intubation CHX on early ET colonization, we will perform microbial cultures of ETs of subjects who are extubated in the first 24 hours of study participation. We will also explore selected biomarkers (procalcitonin, cytokines) as indicators of development of VAP in a subset of subjects. The project will add to knowledge about the relationships among oral health, ET intubation and VAP, and addresses an important clinical outcome. Pre-intubation oral decontamination could reduce risk of VAP and its associated morbidity and mortality.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893763
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298-0567|
|Principal Investigator:||Cindy L Munro, RN,ANP,PHD||Virginia Commonwealth University|