Enhanced Vitals Monitoring for Surgery

Overseen By Nicola Edwards, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Cognitive barriers, Nursing home, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

110 Participants Needed

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.

Research Team

Janny Ke, MD

Principal Investigator

University of British Columbia

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Monitoring

Participants undergo major abdominal or vascular surgery with continuous monitoring of vital signs in-hospital

Up to 30 days postoperatively

Continuous in-hospital monitoring

Enhanced Monitoring

Participants in the intervention group receive enhanced monitoring using devices in-hospital and thrice-daily at home for up to 30 days postoperatively

Up to 30 days postoperatively

Thrice-daily monitoring at home

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up phone call and questionnaire

30 days after surgery

1 follow-up phone call

Treatment Details

Interventions

• Enhanced Vitals Monitoring

Trial Overview 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.

Participant Groups

Group I: Enhanced Vitals Monitoring Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Cloud DX Inc.

Industry Sponsor

Trials

9

Recruited

600+

Excelar

Collaborator

Trials

3

Recruited

180+

3D Bridge Solutions

Collaborator

Trials

1

Recruited

110+

Providence Health & Services

Collaborator

Trials

131

Recruited

827,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Simon Fraser University

Collaborator

Trials

59

Recruited

12,500+

Providence Health Care Ventures

Collaborator

Trials

1

Recruited

110+