Prehospital Ventilator-Associated Pneumonia Prevention Trial

NCT ID: NCT01902446

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-10-31

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.

Conditions

Wounds and Injuries; Respiratory Failure; Pneumonia, Ventilator-Associated

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chlorhexidine gluconate

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.

Chlorhexidine gluconate

Intervention Type: DRUG

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Peridex; PerioGard

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nicholas M Mohr

OTHER

Sponsor Role: lead

Responsible Party

Nicholas M Mohr

Assistant Professor of Emergency Medicine and Anesthesia Critical Care

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicholas M Mohr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

201304766

Identifier Type: -

Identifier Source: org_study_id