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Prehospital Ventilator-Associated Pneumonia Prevention Trial (P-VAPP)

N

Nicholas M Mohr

Status

Completed

Conditions

Pneumonia, Ventilator-Associated
Respiratory Failure
Wounds and Injuries

Treatments

Drug: Chlorhexidine gluconate

Study type

Observational

Funder types

Other

Identifiers

NCT01902446
201304766

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

70 participants in 2 patient groups

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.
Treatment:
Drug: Chlorhexidine gluconate
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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