Strategies To Prevent Pneumonia 2 (SToPP2)
SToPP2
Oral Care Intervention in Mechanically Ventilated Adults
2 other identifiers
interventional
314
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 4, 2009
CompletedFirst Posted
Study publicly available on registry
May 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
January 11, 2016
CompletedJanuary 11, 2016
December 1, 2015
3.8 years
May 4, 2009
June 11, 2015
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of VAP (Clinical Pulmonary Infection Score)
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.
Baseline up to 5 days
Secondary Outcomes (3)
Endotracheal Tube Colonization
24 hours
Serum Cytokines
5 days
Serum Procalcitonin
5 days
Study Arms (2)
Pre-intubation CHX
EXPERIMENTALChlorhexidine applied to oral cavity prior to intubation
Control
ACTIVE COMPARATORNo chlorhexidine applied to oral cavity prior to intubation
Interventions
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.
No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Eligibility Criteria
You may qualify if:
- Need for intubation
You may not qualify if:
- Pneumonia at the time of intubation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298-0567, United States
Related Publications (1)
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.
PMID: 25317722RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cindy L. Munro, APRN, PhD
- Organization
- University of South Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Cindy L Munro, RN,ANP,PHD
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2009
First Posted
May 6, 2009
Study Start
September 1, 2008
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
January 11, 2016
Results First Posted
January 11, 2016
Record last verified: 2015-12