Heart Rate Variability in Trauma Patients

Trauma Clinical Trial

— HRV  

Official title:

Heart Rate Variability in Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795535
• Other study ID #: 20060938
• Status: Completed
• Phase: N/A
• First received: November 19, 2008
• Last updated: February 4, 2015
• Start date: May 2007
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Ryder Trauma Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (1)

Proctor KG, Atapattu SA, Duncan RC. Heart rate variability index in trauma patients. J Trauma. 2007 Jul;63(1):33-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Base Deficit </= -6	Indicator for volume deficit and resuscitation. Number of participants with Base Deficit	Upon arrival to the hospital	No
Primary	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	No
Primary	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	No
Primary	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	No