Strategies To Prevent Pneumonia 2 (SToPP2)

Phase 2

Completed

• Conditions: Ventilator-Associated Pneumonia; Mechanical Ventilation Complication; Infections, Hospital
• Interventions: Procedure: Pre-intubation CHX; Procedure: Control

• Registration Number: NCT00893763
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2015-06-11
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-04
• Last Update Submitted: 2015-12-04
• Results First Posted: 2016-01-11
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

• Need for intubation

Exclusion Criteria

• Pneumonia at the time of intubation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-intubation CHX	Pre-intubation CHX	Chlorhexidine applied to oral cavity prior to intubation
Control	Control	No chlorhexidine applied to oral cavity prior to intubation

Primary Outcome Measures

Name	Time	Method
Development of VAP (Clinical Pulmonary Infection Score)	Baseline up to 5 days	Change between post-intervention CPIS and baseline CPIS. Serial prospective evaluation of VAP risk. 6 elements of CPIS (tracheal secretions, temperature, white blood count, oxygenation, chest radiograph, and tracheal aspirate culture) summed to yield total score of 0-12 daily; higher score reflects greater likelihood of VAP.

Secondary Outcome Measures

Name	Time	Method
Endotracheal Tube Colonization	24 hours	semiquantitative swab culture for potentially pathogenic organisms of distal end of the endotracheal tube (ETT) interior lumen at extubation. Results were collapsed into two categories: colonization (moderate or many organisms) or no colonization.
Serum Cytokines	5 days
Serum Procalcitonin	5 days

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States