Heart Rate Variability in Trauma Patients

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.

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Key information

Conditions

Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ryder Trauma Center

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: HRV

Important dates

Study start: 2007
Primary completion: 2014
Study completion: 2014
First posted: Nov 21, 2008
Registry last updated: Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed