CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 95 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00795535
NCT00795535N/ACompleted

Heart Rate Variability in Trauma Patients

University of Miami·observational·Posted Nov 21, 2008·Updated Feb 9, 2015

In Brief

An observational study for Trauma. Completed, enrolled 95 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTrauma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 21, 2008
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 17.6 years ago