Strategies To Prevent Pneumonia 2 (SToPP2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Virginia Commonwealth University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00893763
First received: May 4, 2009
Last updated: March 31, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Development of VAP (Clinical Pulmonary Infection Score) [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Need for intubation

Exclusion Criteria:

  • Pneumonia at the time of intubation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893763

Contacts
Contact: Cindy L Munro, RN, ANP, PHD 804-828-3410 cmunro@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298-0567
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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