University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
NCT Number: NCT01902446
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.
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Notify Me18 year and older
All sexes
Observational
Iowa City, Iowa, 52242, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Peridex, PerioGard
Time frame: 48-72 hours
Time frame: 5 days
This is the diagnosis of pneumonia within the first 5 days defined by CPIS score >=6.
Time frame: 5 days
This is the diagnosis of pneumonia using CDC criteria within 5 days of admission.
Time frame: 5 days
This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician.
Time frame: 5 days
This is the diagnosis of pneumonia within 5 days as adjudicated by 3 clinicians blinded to treatment allocation.
Time frame: 28 days
Time frame: 28 days
Time frame: 28-days
Time frame: 28 days
Time frame: 48-72 hours
This analysis will be completed in two ways: the raw analysis will use a chi-squared test to test the null hypothesis that the distribution of semi-quantitative tracheal colonization is the same in the two groups. A second analysis will be performed using the ordinal shift method to compare the change (shift) in the semiquantitative score between admission and 48-72 hours.
Nicholas M Mohr
Other
A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients
Acronym: P-VAPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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