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Heart Rate Variability in Trauma Patients (HRV)

This study is currently recruiting participants.
Verified January 2013 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Kenneth Proctor, University of Miami
ClinicalTrials.gov Identifier:
NCT00795535
First received: November 19, 2008
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to develop new triage tool for trauma patients based on HRV. EKG will be prospectively measured in trauma patients in two locations: in the prehospital setting (the field and during transport by helicopter) and in the hospital setting. In each case HRV will be derived from the EKG signal, will be correlated with other non-invasive signals (e.g. near infrared spectroscopy (NIR), and bispectral EEG (BIS)), 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 hypotheses are:

  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Rate Variability in Trauma Patients

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Brain Injury [ Time Frame: Upon arrival to the hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: May 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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 trauma center for presumptive traumatic brain injury. In addition to the EKG, trauma patients may also be connected to either an non-invasive NIR Monitor, which provides real-time information about perfusion status and/or a bispectral EEG monitor, which 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 G Proctor, PhD kproctor@med.miami.edu
Contact: Carl I Schulman, MD cschulman@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 G Proctor, PhD University of Miami
  More Information

Publications:

Responsible Party: Kenneth Proctor, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00795535     History of Changes
Other Study ID Numbers: 20060938
Study First Received: November 19, 2008
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Injury

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013