Prehospital Ventilator-Associated Pneumonia Prevention Trial (P-VAPP)
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.
Wounds and Injuries
Drug: Chlorhexidine gluconate
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients|
- Clinical Pulmonary Infection Score (CPIS) [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
- Pneumonia - CPIS [ Time Frame: 5 days ] [ Designated as safety issue: No ]This is the diagnosis of pneumonia within the first 5 days defined by CPIS score >=6.
- Pneumonia - CDC [ Time Frame: 5 days ] [ Designated as safety issue: No ]This is the diagnosis of pneumonia using CDC criteria within 5 days of admission.
- Pneumonia - Treated [ Time Frame: 5 days ] [ Designated as safety issue: No ]This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician.
- Pneumonia - Research [ Time Frame: 5 days ] [ Designated as safety issue: No ]This is the diagnosis of pneumonia within 5 days as adjudicated by 3 clinicians blinded to treatment allocation.
- 28-day ventilator-free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- 28-day ICU-free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Hospital Mortality [ Time Frame: 28-days ] [ Designated as safety issue: Yes ]
- Tracheostomy Rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Tracheal colonization [ Time Frame: 48-72 hours ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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.
Drug: Chlorhexidine gluconate
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.
Normal saline (placebo)
Intubated subjects assigned transported by another air service will not have any additional treatment (in addition to usual care) during helicopter transport.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01902446
|Contact: Nicholas M Mohr, MDfirstname.lastname@example.org|
|Contact: Azeemuddin Ahmed, MD, MBAemail@example.com|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Nicholas M Mohr, MD 319-353-6360 firstname.lastname@example.org|
|Contact: Trena Thome, BA 319-356-1693 email@example.com|
|Principal Investigator: Nicholas M Mohr, MD|
|Principal Investigator:||Nicholas M Mohr, MD||University of Iowa|