Heart Rate Variability in Trauma Patients (HRV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00795535|
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : December 22, 2014
Last Update Posted : February 9, 2015
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:
- reduced HRV in the field correlates with bad outcome;
- 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;
- an easy to interpret HRV index can be derived that can be used for trauma triage or diagnosis.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||95 participants|
|Official Title:||Heart Rate Variability in Trauma Patients|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
- Base Deficit </= -6 [ Time Frame: Upon 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 Injury [ Time Frame: Upon 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. [ Time Frame: 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 Interval [ Time Frame: Upon 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795535
|United States, Florida|
|Ryder Trauma Center|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Kenneth G Proctor, PhD||University of Miami|