Strategies To Prevent Pneumonia 2 (SToPP2)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nosocomial (Hospital-Acquired) Infections Ventilator-Associated Pneumonia Mechanical Ventilation Endotracheal Intubation |
Procedure: Intervention Procedure: Control |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 325 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: Intervention
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 |
Procedure: Control
No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Need for intubation
Exclusion Criteria:
- Pneumonia at the time of intubation
Contacts and Locations| Contact: Cindy L Munro, RN, ANP, PHD | 804-828-3410 | cmunro@vcu.edu |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298-0567 | |
| Principal Investigator: | Cindy L Munro, RN,ANP,PHD | Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Cindy L. Munro, RN, ANP, PHD, School of Nursing, Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00893763 History of Changes |
| Other Study ID Numbers: | 2R01NR07652, R01NR007652 |
| Study First Received: | May 4, 2009 |
| Last Updated: | March 31, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Virginia Commonwealth University:
|
Nosocomial (Hospital-Acquired) Infections Ventilator-Associated Pneumonia Mechanical ventilation Endotracheal intubation |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury |
ClinicalTrials.gov processed this record on May 23, 2013