Enhanced vitals monitoring after major surgery
The Impact of Enhanced Postoperative Vitals Monitoring In-hospital and at Home vs. Standard Care After Inpatient Abdominal and Vascular Surgery: A Pilot Two-centre Randomized Controlled Study
We will test whether extra in-hospital and at-home continuous vital-sign monitoring helps adults having major abdominal or vascular surgery spend more days alive at home in the first 30 days after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (Vancouver, British Columbia and 1 other locations) |
| Trial ID | NCT06584825 on ClinicalTrials.gov |
What this trial studies
This single-blinded, parallel-group pilot randomized controlled trial will randomize adults undergoing major abdominal or vascular inpatient surgery to enhanced vitals monitoring or standard care. Participants in the intervention arm will use one continuous monitoring device in hospital and a second device at home, complete questionnaires, and receive a follow-up phone call. The primary outcome is days alive and at home within 30 days after surgery (DAH30), with exploratory feasibility analyses and assessments of detection of complications and effects on post-operative management. The trial is conducted at St. Paul's and Mount Saint Joseph hospitals in Vancouver and enrolls patients who expect a hospital stay of at least 48 hours and live within Bell cellular coverage in British Columbia.
Who should consider this trial
Good fit: Ideal candidates are adults having planned inpatient major abdominal or vascular surgery at St. Paul's or Mount Saint Joseph who expect a hospital stay of 48 hours or more, are fluent in English (or have an English-fluent caregiver), and live in British Columbia within Bell cellular network coverage.
Not a fit: Patients unlikely to benefit include transplant recipients (who are excluded), those unable to communicate or operate monitoring devices, people living outside Bell cellular coverage or outside British Columbia, and patients with very short planned hospital stays.
Why it matters
Potential benefit: If successful, enhanced monitoring could detect complications earlier, reduce unplanned readmissions, and increase days alive at home after major surgery.
How similar studies have performed: Previous randomized trials of remote automated monitoring have not consistently increased DAH30—one large RCT of 905 adults showed no DAH30 benefit but did report increased detection of errors, less pain, and possible benefits at centers with higher escalation rates—so evidence to date is mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Undergoing inpatient major abdominal (general surgery, urology, or gynecology) or vascular surgery at St. Paul's Hospital (SPH) and Mount Saint Joseph (MSJ) Hospital 2. 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 3. Self-reported fluency in reading and speaking in English for patient or home caregiver 4. 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: 1. Patient refusal 2. Transplant surgery, since these patients have a unique set of considerations and postoperative course. 3. Inability to communicate with research personnel, perform self-monitoring of vital signs, or complete study surveys due to cognitive, language, visual, or hearing barriers 4. 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) 5. Unable to use (or does not have a caregiver who can help put on/take off) study monitoring device at home 6. Preoperatively known planned discharge to a nursing home or rehabilitation facility 7. Patient with known allergic reactions to any part material of the device 8. 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 9. Unlikely to be able to return the home monitoring kit (no fixed address, living too far away from site, etc.)
Where this trial is running
Vancouver, British Columbia and 1 other locations
- Mount Saint Joseph's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Janny Ke, MD — University of British Columbia
- Study coordinator: Janny Ke, MD
- Email: janny.ke@ubc.ca
- Phone: 604-816-3339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.