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

This study has been completed.
Information provided by (Responsible Party):
University of Iowa Identifier:
First received: July 15, 2013
Last updated: December 2, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Wounds and Injuries
Respiratory Failure
Pneumonia, Ventilator-Associated
Drug: Chlorhexidine gluconate
Phase 2
Phase 3

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Clinical Pulmonary Infection Score (CPIS) [ Time Frame: 48-72 hours ]

Secondary Outcome Measures:
  • Pneumonia - CPIS [ Time Frame: 5 days ]
    This is the diagnosis of pneumonia within the first 5 days defined by CPIS score >=6.

  • Pneumonia - CDC [ Time Frame: 5 days ]
    This is the diagnosis of pneumonia using CDC criteria within 5 days of admission.

  • Pneumonia - Treated [ Time Frame: 5 days ]
    This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician.

  • Pneumonia - Research [ Time Frame: 5 days ]
    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 ]
  • 28-day ICU-free days [ Time Frame: 28 days ]
  • Hospital Mortality [ Time Frame: 28-days ]
  • Tracheostomy Rate [ Time Frame: 28 days ]
  • Tracheal colonization [ Time Frame: 48-72 hours ]
    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.

Enrollment: 70
Study Start Date: July 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
Other Names:
  • Peridex
  • PerioGard
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01902446

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Principal Investigator: Nicholas M Mohr, MD University of Iowa
  More Information

Responsible Party: University of Iowa Identifier: NCT01902446     History of Changes
Other Study ID Numbers: IRB-201304766
Study First Received: July 15, 2013
Last Updated: December 2, 2014

Keywords provided by University of Iowa:
Randomized Controlled Trial
Emergency Medical Services
Intubation, Endotracheal

Additional relevant MeSH terms:
Respiratory Insufficiency
Pneumonia, Ventilator-Associated
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents processed this record on April 26, 2017