Strategies To Prevent Pneumonia 2 (SToPP2) (SToPP2)
Primary Purpose
Infections, Hospital, Ventilator-Associated Pneumonia, Mechanical Ventilation Complication
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pre-intubation CHX
Control
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Hospital focused on measuring Nosocomial (Hospital-Acquired) Infections, Ventilator-Associated Pneumonia, Mechanical ventilation, Endotracheal intubation
Eligibility Criteria
Inclusion Criteria:
- Need for intubation
Exclusion Criteria:
- Pneumonia at the time of intubation
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pre-intubation CHX
Control
Arm Description
Chlorhexidine applied to oral cavity prior to intubation
No chlorhexidine applied to oral cavity prior to intubation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Endotracheal Tube Colonization
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
Serum Procalcitonin
Full Information
NCT ID
NCT00893763
First Posted
May 4, 2009
Last Updated
December 4, 2015
Sponsor
University of South Florida
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00893763
Brief Title
Strategies To Prevent Pneumonia 2 (SToPP2)
Acronym
SToPP2
Official Title
Oral Care Intervention in Mechanically Ventilated Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Hospital, Ventilator-Associated Pneumonia, Mechanical Ventilation Complication
Keywords
Nosocomial (Hospital-Acquired) Infections, Ventilator-Associated Pneumonia, Mechanical ventilation, Endotracheal intubation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
314 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-intubation CHX
Arm Type
Experimental
Arm Description
Chlorhexidine applied to oral cavity prior to intubation
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No chlorhexidine applied to oral cavity prior to intubation
Intervention Type
Procedure
Intervention Name(s)
Pre-intubation CHX
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Primary Outcome Measure Information:
Title
Development of VAP (Clinical Pulmonary Infection Score)
Description
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.
Time Frame
Baseline up to 5 days
Secondary Outcome Measure Information:
Title
Endotracheal Tube Colonization
Description
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.
Time Frame
24 hours
Title
Serum Cytokines
Time Frame
5 days
Title
Serum Procalcitonin
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Need for intubation
Exclusion Criteria:
Pneumonia at the time of intubation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy L Munro, RN,ANP,PHD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0567
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25317722
Citation
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.
Results Reference
result
Learn more about this trial
Strategies To Prevent Pneumonia 2 (SToPP2)
We'll reach out to this number within 24 hrs