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Sponsored by: |
University of Miami |
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Information provided by: | University of Miami |
ClinicalTrials.gov Identifier: | NCT00795535 |
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 |
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Trauma |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Heart Rate Variability in Trauma Patients |
Estimated Enrollment: | 1500 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2011 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All trauma patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenneth Proctor, PhD | kproctor@med.miami.edu | |
Contact: Mark McKenney, PhD | mmckenne@med.miami.edu |
United States, Florida | |
Ryder Trauma Center | Recruiting |
Miami, Florida, United States, 33136 |
Principal Investigator: | Kenneth Proctor, PhD | University of Miami |
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 |
Injury |
Wounds and Injuries Disorders of Environmental Origin |