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Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES) — THRRIVES  

Cancer Clinical Trial

Official title:
Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES)

Clinical Trial Summary

The purpose of this study is to find a way of detecting infection earlier in patients receiving bone marrow transplant. This is accomplished by continuous individualized monitoring of heart rate, respiratory rate and temperature variability in this patient population. The investigators are collecting data to determine whether or not subtle differences in heart rate, respiratory rate and temperature will help physicians to detect infection earlier in order to begin faster treatment before a patient's condition deteriorates. Blood tests will also be performed to check for certain biomarkers that may indicate infection

Clinical Trial Description

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 Biopatch device, a highly compact wireless monitor with two small gel electrodes, that is much more comfortable than previous belt/strap-based monitoring devices. The patient is asked to wear the Zephyr Biopatch 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 Biopatch 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. Bloodwork will also be performed to check for certain biomarkers that may indicate infection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01848912
Study type Observational
Source Ottawa Hospital Research Institute
Contact
Status Completed
Phase
Start date March 2013
Completion date May 2022
View Details
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