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Strategies To Prevent Pneumonia 2 (SToPP2) (SToPP2)

This study has been completed.
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of South Florida Identifier:
First received: May 4, 2009
Last updated: December 4, 2015
Last verified: December 2015
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.

Condition Intervention Phase
Infections, Hospital
Ventilator-Associated Pneumonia
Mechanical Ventilation Complication
Procedure: Pre-intubation CHX
Procedure: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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: 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:
  • Endotracheal Tube Colonization [ Time Frame: 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 [ Time Frame: 5 days ]
  • Serum Procalcitonin [ Time Frame: 5 days ]

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: Pre-intubation CHX
Chlorhexidine applied to oral cavity prior to intubation
Procedure: Pre-intubation CHX
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: Control
No chlorhexidine applied to oral cavity prior to intubation
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Need for intubation

Exclusion Criteria:

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

United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0567
Sponsors and Collaborators
University of South Florida
National Institute of Nursing Research (NINR)
Principal Investigator: Cindy L Munro, RN,ANP,PHD Virginia Commonwealth University
  More Information

Responsible Party: University of South Florida Identifier: NCT00893763     History of Changes
Other Study ID Numbers: 2R01NR007652 ( US NIH Grant/Contract Award Number )
R01NR007652 ( US NIH Grant/Contract Award Number )
Study First Received: May 4, 2009
Results First Received: June 11, 2015
Last Updated: December 4, 2015

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

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Cross Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury
Lung Injury
Iatrogenic Disease
Disease Attributes
Pathologic Processes processed this record on March 27, 2017