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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01902446
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):
Nicholas M Mohr, 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.

Condition or disease Intervention/treatment
Wounds and Injuries Respiratory Failure Pneumonia, Ventilator-Associated Drug: Chlorhexidine gluconate

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Study Type : Observational
Actual Enrollment : 70 participants
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
Study Start Date : July 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Group/Cohort Intervention/treatment
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.

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

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

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

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

  4. Pneumonia - Research [ Time Frame: 5 days ]
    This is the diagnosis of pneumonia within 5 days as adjudicated by 3 clinicians blinded to treatment allocation.

  5. 28-day ventilator-free days [ Time Frame: 28 days ]
  6. 28-day ICU-free days [ Time Frame: 28 days ]
  7. Hospital Mortality [ Time Frame: 28-days ]
  8. Tracheostomy Rate [ Time Frame: 28 days ]
  9. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01902446

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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Nicholas M Mohr
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Principal Investigator: Nicholas M Mohr, MD University of Iowa
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Responsible Party: Nicholas M Mohr, Assistant Professor of Emergency Medicine and Anesthesia Critical Care, University of Iowa Identifier: NCT01902446    
Other Study ID Numbers: 201304766
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Keywords provided by Nicholas M Mohr, University of Iowa:
Randomized Controlled Trial
Emergency Medical Services
Intubation, Endotracheal
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Respiratory Insufficiency
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Cross Infection
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents