Status:
RECRUITING
Enhanced Vitals Monitoring After Major Surgery Trial
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Medtronic
Providence Health Care Ventures
Conditions:
Surgery
Post Operative Complications
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The aim of this clinical trial is to examine the feasibility of an enhanced vital sign monitoring solution in-hospital and at-home. This study includes adult patients undergoing inpatient major vascul...
Detailed Description
After surgeries, patients are at risk of a variety of complications, thus requiring monitoring for early detection and treatment of complications. The current standard of care consists of continuous m...
Eligibility Criteria
Inclusion
- Undergoing inpatient major abdominal (general surgery, urology, or gynecology) or vascular surgery at St. Paul's Hospital (SPH) and Mount Saint Joseph (MSJ) Hospital
- Length of stay of at least 48 hours (planned by the clinical team, or by the Canadian Institute of Health Information Discharge Abstract Database Expected Length of Stay (ELOS) for the surgical case mix group
- Self-reported fluency in reading and speaking in English for patient or home caregiver
- Living within British Columbia, Canada and in an area that is covered by Bell cellular network (the Cloud DX Inc. device has cellular Long Term Evolution (LTE) using the Bell network).
Exclusion
- Patient refusal
- Transplant surgery, since these patients have a unique set of considerations and postoperative course.
- Inability to communicate with research personnel, perform self-monitoring of vital signs, or complete study surveys due to cognitive, language, visual, or hearing barriers
- Lack of capacity to consent to the study (including under the active influence of sedative medication or having received general anesthetic within the past 24 hours)
- Unable to use (or does not have a caregiver who can help put on/take off) study monitoring device at home
- Preoperatively known planned discharge to a nursing home or rehabilitation facility
- Patient with known allergic reactions to any part material of the device
- Unable to monitor blood pressure accurately noninvasively using arm blood pressure cuffs, such as due to underlying vascular anatomy or non-pulsatile blood flow physiology
- Unlikely to be able to return the home monitoring kit (no fixed address, living too far away from site, etc.)
Key Trial Info
Start Date :
November 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06584825
Start Date
November 17 2025
End Date
December 31 2027
Last Update
November 21 2025
Active Locations (2)
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1
Mount Saint Joseph's Hospital
Vancouver, British Columbia, Canada, V5T 3N4
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6