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Completed

NCT Number: NCT01902446

Prehospital Ventilator-Associated Pneumonia Prevention Trial

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chlorhexidine gluconate

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.

Other names: Peridex, PerioGard

Primary outcomes

  1. Clinical Pulmonary Infection Score (CPIS)

    Time frame: 48-72 hours

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nicholas M Mohr

Other

Registry information

Official study title

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

Acronym: P-VAPP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2013
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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