Temperature and Heart and Respiratory Rate Investigation Along With Variability Evaluation (THRRIVE)
In this prospective observational study, patients receiving bone marrow transplant are
selected for continuous monitoring of heart rate, respiratory and temperate variability.
Data is collected as per standard practice using the Zephyr Bioharness device. The fabric
chest strap is properly placed around and above the patient's chest and the Zephyr monitor
is clipped onto the strap.
The patient is asked to wear the Zephyr BioHarness device for approximately 23 hours a day,
beginning the day before he/she begins bone marrow transplant. The patient is asked to
continue wearing the device for a period of up to 10 days or until he/she is no longer
experiencing any fever. The Zephyr BioHarness device records heart rate, respiratory rate
and temperature for calculation of heart rate variability (HRV), respiratory rate
variability (RRV) and temperature variability (TV) using the Continuous Multiorgan
Individualized Variability Analysis (CIMVATM) software engine. The variability outcomes will
look at the presence, rapidity and severity of change in variability prior to the onset,
diagnosis and treatment of infection.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Initiation or broadening of antibiotic for the purpose of treatment of infection
Patients are monitored for a period of up to 10 days or until their white blood cell count goes up, which could take an expected average of 20 days
No
Christopher Bredeson, MD, MSc
Principal Investigator
Ottawa Hospital Research Institute
Canada: Ethics Review Committee
20120564-01H
NCT01848912
March 2013
December 2013
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