A Pilot Study to Evaluate the Feasibility of Mobile Monitoring of Vital Signs in Opioid Users
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Participant compliance: Proportion of participants who wear the device
Study Overview
Brief Summary
Opioid dependence and its associated harms are becoming increasingly prevalent in North America, with overdose now being the second leading cause of accidental death in the US. This pilot study will investigate the feasibility of a novel mobile device to monitor vital signs in both opioid-injecting individuals and hospital inpatients who are on high-dose oral opioids. A secondary goal is to explore associations between consumption and changes in vital signs post-injection with the long-term goal of developing a mobile system that will alert clinicians when patients are at risk of overdose so that appropriate interventions can be delivered in time.
Detailed Description
- 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.
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •19 to 64 years of age, inclusive;
- •Current and ongoing injection drug use with opioids OR hospitalized inpatients under the care of the St. Paul's Hospital Addiction Medicine Consult Team with current and ongoing use of high dose oral opioid medications;
- •Current and past history of an opioid use disorder;
- •Ability to communicate in English; and
- •Ability to provide written informed consent and comply with study procedures.
Exclusion Criteria
- •Inability to understand study procedures due to changed health and/or mental status;
- •Chest circumference greater than 115 cm;
- •Women who are pregnant or breastfeeding
- •Has a pacemaker or automatic cardioverter defibrillator (AICD) in situ;
- •Diagnosed with atrial fibrillation;
- •Have other medical devices (i.e. insulin pump) that precludes the use of the device;
- •Allergies or skin conditions that preclude the use of adhesive electrodes; and
- •Any other condition that, in the judgment of the investigator, presents a contraindication to study participation.
Arms & Interventions
Mobile monitoring device arm
Canary 01 Mobile Vital Signs Monitoring Device
Intervention: Canary 01 Mobile Vital Signs Monitoring Device (Device)
Outcomes
Primary Outcomes
Participant compliance: Proportion of participants who wear the device
Time Frame: For Visit 2, Visit 3 and Visit 4 (>100 minutes per 120minute session). Visits will take place over an average of 3 weeks
Proportion of participants who wear the device for \>100 minutes per 120 minute session as reported by participants and observed by the study coordinator/nurse.
Feasibility: Proportion of participant sessions with continuous transmission of vital signs data
Time Frame: For Visit 2, Visit 3 and Visit 4( >100 minutes per 120 minute session). Visits will take place over an average of 3 weeks
Proportion of participant sessions with continuous transmission of vital signs data for \>100 minutes per 120 minute session
Clinical utility
Time Frame: through study completion
Compiled scores and summary data (means, medians, ranges) from participant \& clinician usability surveys.
Secondary Outcomes
- Study retention and drop-out rates(Through study completion, an average of 3 weeks per participant)
- Premature device removal event counts and rates (participant or clinician initiated);(Through study completion, an average of 3 weeks per participant.)
- Reliability of device as measured by artefact and transmission failure rates;(Through study completion, an average of 3 weeks per participant)
- Characterization of physiological changes following opioid consumption;(For Visit 2, Visit 3 and Visit 4 for 120 minutes. Visits will take place over an average of 3 weeks)
- For a subset of participants enrolled in the hospital, accuracy of data recorded by the device in comparison to data collected by bedside monitoring equipment(For Visit 2, Visit 3 and Visit 4 at various time points per 120 minute session.Visits will take place over an average of 3 weeks per participant.)
Investigators
Keith Ahmad
Dr Keith Ahmad
University of British Columbia