Temperature and Heart and Respiratory Rate Investigation Along With Variability Evaluation (THRRIVE)
18 Years
N/A
Both
Cancer
Trial Information
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.
Inclusion Criteria:
An expected prolonged period of neutropenia
- Completing bone marrow;
- Allogeneic and/or autologous transplants OR
- Induction chemotherapy
Exclusion Criteria:
- Inability to obtain written informed consent from patient or legally authorized
representative
- Ongoing treatment for active infection (not prophylaxis)
- Preexisting severe cardiopulmonary disease (defined as an EF 40%, FEV 40%,or
interstitial lung disease with pulmonary fibrosis)
- On betablockers or calcium channel blockers
- Preexisting arrhythmia
- Permanent pacemaker
- Inability to speak neither English nor French
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Initiation or broadening of antibiotic for the purpose of treatment of infection
Outcome Time Frame:
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
Safety Issue:
No
Principal Investigator
Christopher Bredeson, MD, MSc
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ottawa Hospital Research Institute
Authority:
Canada: Ethics Review Committee
Study ID:
20120564-01H
NCT ID:
NCT01848912
Start Date:
March 2013
Completion Date:
December 2013
Related Keywords:
- Cancer
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