A Pilot Study to Evaluate the Feasibility of Mobile Monitoring of Vital Signs in Opioid Users

1. PURPOSE The purpose of the pilot study is to assess feasibility of a novel device (Canary 01 Mobile Vital Signs Monitoring Device) in individuals who inject opioids and in hospital inpatients who are on high-dose oral opioid medications. The primary objectives are to evaluate if the device can reliably and comfortably be worn for an extended duration of time following opioid consumption and can accurately monitor changes in vital signs (electrocardiogram (ECG), heart rate, respiratory rate) in this clinical population and setting. A secondary purpose of the study is to enrich our understanding of changes in vital signs that occur post-opioid-consumption. The long-term goal of the study is to create a device that will allow clinicians and patients to detect adverse effects of opioid consumption early (i.e. respiratory depression), so that appropriate treatment interventions can be delivered to prevent overdose-related morbidity and mortality.
2. HYPOTHESES The team hypothesizes that the Canary 01 Mobile Vital Signs Monitoring Device will prove to be a feasible and reliable device for monitoring vital signs before and after consumption of opioids, among individuals who inject opioids and among individuals who are on high doses of opioid medication.
3. JUSTIFICATION Opioid medications are key agents for treating acute pain, cancer pain, and are deemed to be essential medicines for pain care by the World Health Organization. However, opioid medications have a serious side effect profile including contributing to delirium, oversedation and respiratory depression in the event of overdose. Between 2005 and 2009, there were 815 deaths related to fentanyl, hydromorphone, morphine and oxycodone in British Columbia. Opioid overdose is now the second leading cause of accidental death in the United States.

In addition to adverse events, opioids are known to be highly addictive. In Canada, there were an estimated 75,000-125,000 injection drug users (the vast majority of them who injected opioids) as well as approximately 200,000 people with prescription opioid dependence, as of 2012.

Knowledge gained in this innovative pilot study will inform development of a mobile monitoring device designed to alert clinicians of cardiopulmonary changes indicating opioid overdose in patients, allowing for rapid detection, intervention and administration of potentially life-saving treatment. Ultimately, clinical implementation of this device could lead to a reduction in the substantial morbidity and mortality attributable to opioid-related overdoses.

In addition, through fulfillment of our secondary objective, this feasibility study will contribute new knowledge regarding changes in cardiopulmonary status associated with use of high opioid doses. 4. OBJECTIVES

Primary Objective To determine whether a mobile monitoring system for specific vital signs (e.g., heart rate and respiratory rate) can be used successfully in the monitoring of opioid dependent individuals.