Trial record 3 of 142 for:    "Pneumonia, Ventilator-Associated"

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

This study is currently recruiting participants.
Verified November 2013 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01902446
First received: July 15, 2013
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pneumonia - CPIS [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    This is the diagnosis of pneumonia within the first 5 days defined by CPIS score >=6.

  • Pneumonia - CDC [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    This is the diagnosis of pneumonia using CDC criteria within 5 days of admission.

  • Pneumonia - Treated [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician.

  • Pneumonia - Research [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 28-day ICU-free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Hospital Mortality [ Time Frame: 28-days ] [ Designated as safety issue: Yes ]
  • Tracheostomy Rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Tracheal colonization [ Time Frame: 48-72 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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

Contacts
Contact: Nicholas M Mohr, MD 319-353-6360 nicholas-mohr@uiowa.edu
Contact: Azeemuddin Ahmed, MD, MBA 319-356-7306 azeemuddin-ahmed@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Nicholas M Mohr, MD    319-353-6360    nicholas-mohr@uiowa.edu   
Contact: Trena Thome, BA    319-356-1693    trena-thome@uiowa.edu   
Principal Investigator: Nicholas M Mohr, MD         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Nicholas M Mohr, MD University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01902446     History of Changes
Other Study ID Numbers: IRB-201304766
Study First Received: July 15, 2013
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Pneumonia
Wounds and Injuries
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014