A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients
Prehospital Ventilator-Associated Pneumonia Prevention Trial
Sponsors
Source
University of Iowa
Oversight Info
Has Dmc
Yes
Brief Summary
Traumatic injury in rural America is a significant cause of morbidity and mortality, and the
challenges of a rural trauma system can put patients at unique risk. Prolonged transport
times to a trauma center, stopping for care at referring hospitals, and longer exposure to
care-associated factors distinguish rural patients from their urban counterparts.
Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing
hospital stay, healthcare costs, and even mortality in the critically injured. The
investigators propose a pilot study to test the hypothesis that a single dose of oral
chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will
decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy
in intensive care units to prevent airway colonization and subsequent development of VAP.
Demonstrating safety and effectiveness of prehospital infection control practices could
significantly improve outcomes of traumatic injury in rural America.
Overall Status
Completed
Start Date
2013-07-01
Completion Date
2014-10-01
Primary Completion Date
2014-10-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Clinical Pulmonary Infection Score (CPIS) |
48-72 hours |
Secondary Outcome
Measure |
Time Frame |
|
Pneumonia - CPIS |
5 days |
|
Pneumonia - CDC |
5 days |
|
Pneumonia - Treated |
5 days |
|
Pneumonia - Research |
5 days |
|
28-day ventilator-free days |
28 days |
|
28-day ICU-free days |
28 days |
|
Hospital Mortality |
28-days |
|
Tracheostomy Rate |
28 days |
|
Tracheal colonization |
48-72 hours |
Number Of Groups
2
Enrollment
70
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
Study solution will be applied to the oropharynx and will be distributed for 15 seconds with a swab stick. No suction will be applied for at least 30 seconds.
Arm Group Label
Chlorhexidine gluconate
Other Name
Peridex
PerioGard
Eligibility
Study Pop
All intubated adult patients transported by air ambulance to the University of Iowa
Hospitals and Clinics in interfacility transport after traumatic injury.
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
- Adults (age >= 18 years)
- Endotracheal intubation
- Transported by air ambulance
- Traumatic injury
- Interfacility transport (no flights from scene) en route to University of Iowa
Hospitals and Clinics)
Exclusion Criteria:
- Known or suspected pregnancy
- Prisoners
- Patients diagnosed with pneumonia prior to transfer
- Known allergy to chlorhexidine gluconate
- Surgical airway (tracheostomy or cricothyroidotomy)
- Massive aspiration
- Anticipated nonsurvivable injury (survival projected < 24 hours)
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Nicholas M Mohr, MD |
Principal Investigator |
University of Iowa |
Location
Facility |
|
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 United States |
Location Countries
Country
United States
Verification Date
2017-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
University of Iowa
Investigator Full Name
Nicholas M Mohr
Investigator Title
Assistant Professor of Emergency Medicine and Anesthesia Critical Care
Keywords
Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Chlorhexidine
Chlorhexidine gluconate
Arm Group
Arm Group Label
Chlorhexidine gluconate
Description
Intubated subjects transported by one air service will be treated with 5 mL chlorhexidine gluconate 0.12% applied for at least 30 seconds during helicopter transport.
Arm Group Label
Normal saline (placebo)
Description
Intubated subjects assigned transported by another air service will not have any additional treatment (in addition to usual care) during helicopter transport.
Firstreceived Results Date
N/A
Acronym
P-VAPP
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
July 15, 2013
Study First Submitted Qc
July 17, 2013
Study First Posted
July 18, 2013
Last Update Submitted
June 7, 2017
Last Update Submitted Qc
June 7, 2017
Last Update Posted
June 9, 2017
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.