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Heart Rate Variability in Trauma Patients

Completed
Conditions
Trauma
Registration Number
NCT00795535
Lead Sponsor
University of Miami
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
95
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 Traumtaic Brain Injury
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Base Deficit </= -6Upon arrival to the hospital

Indicator for volume deficit and resuscitation. Number of participants with Base Deficit \</= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit \</= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.

Serious InjuryUpon arrival to the hospital

A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.

Life Saving Intervention in the Operating Room.Upon arrival to the hospital

A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.

SDNN: Standard Deviation of the Normal-to-normal R-R IntervalUpon arrival to the hospital

A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ryder Trauma Center

🇺🇸

Miami, Florida, United States

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