Heart Rate Variability in Trauma Patients

NCT ID: NCT00795535

Last Updated: 2015-02-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Proctor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth G Proctor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Ryder Trauma Center

Miami, Florida, United States

Site Status

Countries

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United States

References

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Proctor KG, Atapattu SA, Duncan RC. Heart rate variability index in trauma patients. J Trauma. 2007 Jul;63(1):33-43. doi: 10.1097/01.ta.0000251593.32396.df.

Reference Type BACKGROUND
PMID: 17622866 (View on PubMed)

Other Identifiers

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20060938

Identifier Type: -

Identifier Source: org_study_id

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