Strategies To Prevent Pneumonia 2 (SToPP2)

University of South Florida

Status and phase: Completed; Phase 2

Conditions: Infections, Hospital; Ventilator-Associated Pneumonia; Mechanical Ventilation Complication

Treatments: Procedure: Pre-intubation CHX; Procedure: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00893763

R01NR007652 (U.S. NIH Grant/Contract)

2R01NR007652

Details and patient eligibility

About

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.

Full 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.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Need for intubation

Exclusion criteria

• Pneumonia at the time of intubation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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314 participants in 2 patient groups

Pre-intubation CHX

Experimental group

Description:

Chlorhexidine applied to oral cavity prior to intubation

Treatment:

Procedure: Pre-intubation CHX

Control

Active Comparator group

Description:

No chlorhexidine applied to oral cavity prior to intubation

Treatment:

Procedure: Control