Enhanced Vitals Monitoring After Major Surgery Trial (NCT06584825) | Clinical Trial Compass
RecruitingNot Applicable
Enhanced Vitals Monitoring After Major Surgery Trial
Canada110 participantsStarted 2025-11-17
Plain-language 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 vascular or abdominal surgery. Researchers will compare the enhanced vitals monitoring group to the standard of care group to see if it may change post-operative management and outcomes. The primary question it aims to answer is if enhanced monitoring of surgical patient vitals can increase the number of days at home alive in the first 30 days after surgery. Participants in the intervention group will test two vitals monitoring devices, one in the hospital and one at home. They will also be asked to complete several questionnaires and a follow up phone call.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
✕
What they're measuring
1
Days Alive At Home (DAH30)
Timeframe: Within 30 days after surgery, with the day of surgery as day 0
. 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