Clinical trial NCT01902446: Prehospital Ventilator-Associated Pneumonia Prevention Trial
Official title: A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds and Injuries
Respiratory Failure
Pneumonia, Ventilator-Associated
Keywords: Chlorhexidine
Randomized Controlled Trial
Emergency Medical Services
Intubation, Endotracheal
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All intubated adult patients transported by air ambulance to the University of Iowa Hospitals and Clinics in interfacility transport after traumatic injury.

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.


Eligibility 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)

Primary outcomes:
measure: Clinical Pulmonary Infection Score (CPIS)
timeFrame: 48-72 hours
Secondary outcomes:
measure: Pneumonia - CPIS
timeFrame: 5 days
measure: Pneumonia - CDC
timeFrame: 5 days
measure: Pneumonia - Treated
timeFrame: 5 days
measure: Pneumonia - Research
timeFrame: 5 days
measure: 28-day ventilator-free days
timeFrame: 28 days
measure: 28-day ICU-free days
timeFrame: 28 days
measure: Hospital Mortality
timeFrame: 28-days
measure: Tracheostomy Rate
timeFrame: 28 days
measure: Tracheal colonization
timeFrame: 48-72 hours
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Nicholas M Mohr, MD
role: PRINCIPAL_INVESTIGATOR
References: