Heart Rate Variability in Trauma Patients

NCT00795535 | Completed Results

• 1 other identifier: 20060938
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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. 1.reduced HRV in the field correlates with bad outcome;
2. 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. 3.an easy to interpret HRV index can be derived that can be used for trauma triage or diagnosis.

Conditions

Trauma

Keywords

Injury

Outcome Measures

Primary Outcomes (4)

• Base Deficit </= -6

  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.

  Upon arrival to the hospital

• Serious Injury

  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.

  Upon arrival to the hospital

• Life Saving Intervention in the Operating Room.

  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.

  Upon arrival to the hospital

• SDNN: Standard Deviation of the Normal-to-normal R-R Interval

  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.

  Upon arrival to the hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All trauma patients

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Ryder Trauma Center

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 17622866 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Kenneth Proctor, PhD, Professor of Surgery
• Organization: University of Miami

kproctor@med.miami.edu

305-355-4960

Study Officials

• Kenneth G Proctor, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 21, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 9, 2015
• Results First Posted: December 22, 2014

Record last verified: 2015-02

Locations

US (1)