Strategies To Prevent Pneumonia 2 (SToPP2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00893763
First received: May 4, 2009
Last updated: August 19, 2013
Last verified: August 2013
  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 University of South Florida:

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 ]

Enrollment: 314
Study Start Date: September 2008
Study Completion Date: June 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893763

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0567
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Cindy L Munro, RN,ANP,PHD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00893763     History of Changes
Other Study ID Numbers: 2R01NR07652, R01NR007652
Study First Received: May 4, 2009
Last Updated: August 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of South Florida:
Nosocomial (Hospital-Acquired) Infections
Ventilator-Associated Pneumonia
Mechanical ventilation
Endotracheal intubation

Additional relevant MeSH terms:
Infection
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on September 22, 2014