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

Ottawa Hospital Research Institute

Status: Completed

Conditions: Cancer

Treatments: Device: Zephyr Biopatch Device

Study type: Observational

Funder types: Other

Identifiers

NCT01848912

20120564-01H

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 1 patient group

Bone Marrow Transplant Patients

Treatment:

Device: Zephyr Biopatch Device