Actively Recruiting
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
Led by University of British Columbia · Updated on 2025-11-21
110
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of an enhanced vital sign monitoring solution for adults undergoing major abdominal or vascular surgery. This study compares enhanced monitoring of vital signs both in the hospital and at home to the standard care, aiming to see if this can increase the number of days patients are alive and at home within 30 days after surgery. The study also addresses the challenge that current vital sign monitoring after surgery may miss important changes in a patient's condition, especially once patients leave the hospital. Participants in the intervention group will receive additional continuous vital sign monitoring in the hospital from 8am to 5pm starting the day of surgery until 3 days after surgery or discharge, using a Philips monitor that tracks heart rate, oxygen saturation, and blood pressure. After discharge, they will use a Cloud DX Inc. home monitoring kit twice daily for 3 days. The control group will receive standard monitoring in the hospital and usual follow-up after discharge. Both groups will complete questionnaires 14 and 30 days after surgery, and a follow-up phone call will be conducted at 30 days. Participants will be closely monitored through questionnaires and vital sign measurements during hospitalization and at home. Researchers will assess outcomes such as days alive at home within 30 days after surgery, quality of recovery, major morbidity, mortality, emergency visits, readmissions, and length of hospital stay. The study also includes protocols for clinical escalation if vital signs exceed alert thresholds. The total participation involves in-hospital monitoring followed by home monitoring and follow-up assessments up to 30 days postoperatively.
CONDITIONS
Brief Title
Enhanced Vitals Monitoring After Major Surgery Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing inpatient major abdominal (general surgery, urology, or gynecology) or vascular surgery at St. Paul's Hospital or Mount Saint Joseph Hospital
- Planned hospital stay of at least 48 hours
- Able to read and speak English for patient or home caregiver
- Living within British Columbia in an area covered by the Bell cellular network
You will not qualify if you...
- Patient refusal to participate
- Undergoing transplant surgery
- Unable to communicate with research staff or perform self-monitoring due to cognitive, language, visual, or hearing barriers
- Lacking capacity to consent, including under influence of sedatives or recent general anesthesia
- Unable to use or lack a caregiver to help use monitoring devices at home
- Planned discharge to nursing home or rehabilitation facility
- Known allergies to device materials
- Unable to measure blood pressure accurately with arm cuffs
- Unlikely to return the home monitoring kit due to no fixed address or living too far away
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 days (day of surgery plus 3 days post-surgery or until discharge)
Participants undergo major abdominal or vascular surgery followed by continuous vital signs monitoring in-hospital from 8am to 5pm starting the day of surgery until 3 days after surgery or discharge, whichever occurs first. This includes heart rate and oxygen saturation continuously and blood pressure hourly while awake, with clinical escalation protocols if needed.
Continuous monitoring during daytime hours in hospital
Duration - 3 days after discharge plus follow-up to 30 days after surgery
After discharge, participants in the enhanced monitoring group perform twice-daily vital sign monitoring at home for 3 days with clinical escalation protocols if needed. Participants in the standard care group receive usual care without home monitoring. The research team collects questionnaire data at 14 and 30 days postoperatively and conducts a 30-day phone follow-up.
Twice-daily home monitoring for 3 days and 2 follow-up questionnaire contacts plus 1 phone call within 30 days
Trial Site Locations
Total: 2 locations
1
Mount Saint Joseph's Hospital
Vancouver, British Columbia, Canada, V5T 3N4
Actively Recruiting
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
Research Team
J
Janny Ke, MD
N
Nicola Edwards, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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