Clinical trial NCT00893763: Strategies To Prevent Pneumonia 2 (SToPP2)
Official title: Oral Care Intervention in Mechanically Ventilated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Hospital
Ventilator-Associated Pneumonia
Mechanical Ventilation Complication
Keywords: Nosocomial (Hospital-Acquired) Infections
Ventilator-Associated Pneumonia
Mechanical ventilation
Endotracheal intubation
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2009-05-06
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Need for intubation

Exclusion Criteria:

* Pneumonia at the time of intubation

Primary outcomes:
measure: Development of VAP (Clinical Pulmonary Infection Score)
timeFrame: Baseline up to 5 days
Secondary outcomes:
measure: Endotracheal Tube Colonization
timeFrame: 24 hours
measure: Serum Cytokines
timeFrame: 5 days
measure: Serum Procalcitonin
timeFrame: 5 days
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Cindy L Munro, RN,ANP,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munro CL, Grap MJ, Sessler CN, Elswick RK Jr, Mangar D, Karlnoski-Everall R, Cairns P. Preintubation application of oral chlorhexidine does not provide additional benefit in prevention of early-onset ventilator-associated pneumonia. Chest. 2015 Feb;147(2):328-334. doi: 10.1378/chest.14-0692.