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Strategies To Prevent Pneumonia 2 (SToPP2) (SToPP2)

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ClinicalTrials.gov Identifier: NCT00893763
Recruitment Status : Completed
First Posted : May 6, 2009
Results First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of South Florida

May 4, 2009
May 6, 2009
June 11, 2015
January 11, 2016
January 11, 2016
September 2008
June 2012   (Final data collection date for primary outcome measure)
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.
Development of VAP (Clinical Pulmonary Infection Score) [ Time Frame: 5 days ]
Complete list of historical versions of study NCT00893763 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Endotracheal Tube Colonization [ Time Frame: 24 hours ]
  • Serum Cytokines [ Time Frame: 5 days ]
  • Serum Procalcitonin [ Time Frame: 5 days ]
Not Provided
Not Provided
 
Strategies To Prevent Pneumonia 2 (SToPP2)
Oral Care Intervention in Mechanically Ventilated Adults
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Infections, Hospital
  • Ventilator-Associated Pneumonia
  • Mechanical Ventilation Complication
  • 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.
  • Procedure: Control
    No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
  • Experimental: Pre-intubation CHX
    Chlorhexidine applied to oral cavity prior to intubation
    Intervention: Procedure: Pre-intubation CHX
  • Active Comparator: Control
    No chlorhexidine applied to oral cavity prior to intubation
    Intervention: Procedure: Control
Munro CL, Grap MJ, Sessler CN, Elswick RK Jr, Mangar D, Karlnoski-Everall R, Cairns P. Preintubation application of oral chlorhexidine does not provide additional benefit in prevention of early-onset ventilator-associated pneumonia. Chest. 2015 Feb;147(2):328-334. doi: 10.1378/chest.14-0692.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
325
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Need for intubation

Exclusion Criteria:

  • Pneumonia at the time of intubation
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00893763
2R01NR007652( U.S. NIH Grant/Contract )
R01NR007652 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of South Florida
University of South Florida
National Institute of Nursing Research (NINR)
Principal Investigator: Cindy L Munro, RN,ANP,PHD Virginia Commonwealth University
University of South Florida
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP