Strategies To Prevent Pneumonia 2 (SToPP2) (SToPP2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00893763
Recruitment Status : Completed
First Posted : May 6, 2009
Results First Posted : January 11, 2016
Last Update Posted : January 11, 2016
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Oral Care Intervention in Mechanically Ventilated Adults
Study Start Date : September 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Serum Cytokines [ Time Frame: 5 days ]
  3. Serum Procalcitonin [ Time Frame: 5 days ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Need for intubation

Exclusion Criteria:

  • Pneumonia at the time of intubation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: University of South Florida Identifier: NCT00893763     History of Changes
Other Study ID Numbers: 2R01NR007652 ( U.S. NIH Grant/Contract )
R01NR007652 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2009    Key Record Dates
Results First Posted: January 11, 2016
Last Update Posted: January 11, 2016
Last Verified: December 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