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Heart Rate Variability in Trauma Patients (HRV)
This study is currently recruiting participants.
Verified by University of Miami, August 2008
Sponsored by: University of Miami
Information provided by: University of Miami
ClinicalTrials.gov Identifier: NCT00795535
  Purpose

The purpose of this study is to develop new triage tool for trauma patients based on HRV. The investigators intend to prospectively measure EKG in trauma patients in two locations: in the prehospital (the field and during transport by helicopter) and in the hospital setting. In each case HRV will be measured for 5 min and is derived from the EKG signal. HRV, NIR, and BIS readings, along with other routinely measured variables (blood pressure, respiratory rate, pulse oximetry, etc), will be correlated with injury severity and day of discharge. An algorithm will be constructed using multiple linear regression. The investigators hypothesize that: 1) reduced HRV in the field correlates with bad outcome; 2) the specificity and efficiency of HRV as a screening tool can be improved by controlling factors such as heart rate, age, gender, respiratory rate, and pulse oxygen saturation; 3) an easy to interpret HRV index can be derived that can be used for trauma triage or diagnosis.


Condition
Trauma

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Heart Rate Variability in Trauma Patients

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Injury Severity Score [ Time Frame: Upon arrival to the hospital ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 1500
Study Start Date: May 2007
Estimated Study Completion Date: June 2011
Detailed Description:

The eligible study population will be comprised of patients who meet level 1 trauma criteria and are transported by helicopter to Ryder Trauma Center or who are already admitted to the hospital. At the scene of the accident, or during transport, most of the patients will have routine EKG leads placed by the paramedic. In those individuals, the paramedic will connect EKG leads to a GE Mars Holter Monitor, in addition to whatever other monitor is used as part of the standard of care. Similarly, NIR (Near-Infrared Spectroscopy) will be used through the Inspectra Tissue Oxygenation Monitor and BIS (Bispectral index monitor) readings will be employed by research personnel for additional correlations to better identify those with severe injury. The HRV data will be correlated with one or more outcome variables in the trauma patients, then an easy to interpret index will be derived, as defined in our previous study.

In addition to the EKG, trauma patients who are being monitored for heart rate variability will also be connected to an Inspectra Tissue Oxygenation Monitor and Aspect BIS EEG monitor, both of which derive information from non-invasive surface probes. The Inspectra Tissue Oxygenation Monitor provides real-time information about perfusion status and the Aspect BIS EEG monitor provides real-time information about brain metabolic activity.

  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 trauma patients

Criteria

Inclusion Criteria:

  • Patients who meet level 1 trauma criteria and are transported by helicopter to Ryder Trauma Center
  • An additional study population will be comprised of patients already admitted to the trauma center for presumptive TBI

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795535

Contacts
Contact: Kenneth Proctor, PhD kproctor@med.miami.edu
Contact: Mark McKenney, PhD mmckenne@med.miami.edu

Locations
United States, Florida
Ryder Trauma Center Recruiting
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Kenneth Proctor, PhD University of Miami
  More Information

Responsible Party: University of Miami ( Kenneth Proctor, Professor of Surgery )
Study ID Numbers: 20060938
Study First Received: November 19, 2008
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00795535  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Injury

Study placed in the following topic categories:
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 14, 2009