Prehospital Ventilator-Associated Pneumonia Prevention Trial

A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients

Sponsors

Lead Sponsor: Nicholas M Mohr

Source University of Iowa
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.

Overall Status Completed
Start Date July 2013
Completion Date October 2014
Primary Completion Date October 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Clinical Pulmonary Infection Score (CPIS) 48-72 hours
Secondary Outcome
Measure Time Frame
Pneumonia - CPIS 5 days
Pneumonia - CDC 5 days
Pneumonia - Treated 5 days
Pneumonia - Research 5 days
28-day ventilator-free days 28 days
28-day ICU-free days 28 days
Hospital Mortality 28-days
Tracheostomy Rate 28 days
Tracheal colonization 48-72 hours
Enrollment 70
Condition
Intervention

Intervention Type: Drug

Intervention Name: Chlorhexidine gluconate

Description: 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.

Arm Group Label: Chlorhexidine gluconate

Eligibility

Sampling Method: Non-Probability Sample

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Nicholas M Mohr, MD Principal Investigator University of Iowa
Location
Facility: University of Iowa Hospitals and Clinics
Location Countries

United States

Verification Date

June 2017

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Iowa

Investigator Full Name: Nicholas M Mohr

Investigator Title: Assistant Professor of Emergency Medicine and Anesthesia Critical Care

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 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.

Label: 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.

Acronym P-VAPP
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov