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Behavioural Intervention

Enhanced Vitals Monitoring for Surgery

N/A
Waitlist Available
Led By Janny Ke, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing inpatient vascular surgery or abdominal surgery (general surgery, gynecology, and urology, except transplant surgery) at St. Paul's Hospital
Be older than 18 years old
Must not have
Patient refusal
Preoperatively known planned discharge to a nursing home or rehabilitation facility
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperatively, at the time of recruitment, up to 1 month prior to surgery.
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test a new way of monitoring patients' vital signs during and after surgery. They will compare this new method to the current standard of care to see if it can improve patient outcomes.

Who is the study for?
This trial is for adults in British Columbia, Canada who are having medium- to high-risk vascular or abdominal surgery at St. Paul's Hospital and expect to stay there for at least 48 hours. They should be able to read and speak English (or have a caregiver who can) and live in an area with Bell cellular network coverage.
What is being tested?
Researchers are testing if enhanced vital sign monitoring both in the hospital and at home after surgery can improve recovery outcomes compared to standard care. Participants will use two different devices for monitoring their vitals and answer questionnaires, with a follow-up call.
What are the potential side effects?
Since this trial involves non-invasive vital signs monitoring, side effects may not be directly related but could include discomfort from wearing the device or potential stress from continuous health data tracking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for inpatient vascular or abdominal surgery at St. Paul's Hospital, excluding transplant surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have chosen not to participate in certain treatments or procedures.
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I plan to go to a nursing home or rehab facility after surgery.
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I can communicate and perform self-monitoring without any barriers.
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I am able to understand and consent to participate in the study without being under sedation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperatively, at the time of recruitment, up to 1 month prior to surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively, at the time of recruitment, up to 1 month prior to surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Days Alive At Home (DAH30)
Secondary study objectives
Emergency Department visit(s) after discharge
Family doctor clinic visit(s)
Major Morbidity
+7 more
Other study objectives
Adverse Events
At-Home Enhanced Monitoring Device System Usability Scale
Care escalation frequency
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Vitals MonitoringExperimental Treatment1 Intervention
Enhanced (i.e. additional) monitoring using Health Canada approved devices in-hospital followed by thrice-daily monitoring at home 7 days after discharge (up to a maximum of 30 days postoperatively in total), with a protocol for clinical escalation if vital sign alert thresholds are exceeded.
Group II: Standard CareActive Control1 Intervention
Standard vitals monitoring in hospital and standard of care follow-up procedures once discharged home. The research team will administer a 30 day phone call and questionnaire.

Find a Location

Who is running the clinical trial?

Cloud DX Inc.Industry Sponsor
8 Previous Clinical Trials
485 Total Patients Enrolled
ExcelarUNKNOWN
2 Previous Clinical Trials
65 Total Patients Enrolled
3D Bridge SolutionsUNKNOWN
~73 spots leftby Feb 2025
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