NCT00893763

Strategies To Prevent Pneumonia 2 (SToPP2)

Oral Care Intervention in Mechanically Ventilated Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ventilator-associated pneumonia (VAP) 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.

Detailed description

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.

Conditions

• Infections, Hospital
• Ventilator-Associated Pneumonia
• Mechanical Ventilation Complication

Interventions

Type	Name	Description
PROCEDURE	Pre-intubation CHX	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.
PROCEDURE	Control	No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-05-06
• Last updated: 2016-01-11
• Results posted: 2016-01-11

Locations

1 site across 1 country: United States