Enhanced Vitals Monitoring for Surgery

Recruiting in Palo Alto (17 mi)

Overseen byJanny Ke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of British Columbia

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 medium- to high-risk 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.

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for inpatient vascular or abdominal surgery at St. Paul's Hospital, excluding transplant surgery.

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

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Exclusion Criteria

I can communicate and perform self-monitoring without any barriers.

Unable to use (or does not have a caregiver who can help put on/take off) study monitoring device at home

Patient with known allergic reactions to any part material of the device

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Treatment Details

Interventions

Enhanced Vitals Monitoring (Behavioural Intervention)

Trial OverviewResearchers 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.

Participant Groups

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.