Enhanced Vitals Monitoring After Major Surgery Trial

Summary

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 major 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.

Conditions

• Surgery
• Post Operative Complications
• Quality of Recovery
• General Surgery
• Vascular Surgery
• Urology
• Gynecology

Interventions

DEVICE

Enhanced Vitals Monitoring

For participants in the intervention group, they will receive the enhanced continuous vital sign monitoring, on top of the standard of care monitoring as prescribed per the care team. The enhanced monitoring will be provided during in-hospital postoperatively, 8am to 5pm from the day of surgery until 3 days after surgery or until discharged (whichever occurs first) with a protocol for clinical escalation if vital sign alert thresholds are exceeded, using the Philips monitor (i.e. heart rate and oxygen saturation continuously and blood pressure once an hour while awake). Participants and caregivers will be educated how to put on and off the devices by the study coordinator. When participants return home, they will perform twice-daily monitoring using the Cloud DX Inc. Home kit and daily questionnaires at home for 3 days after discharge, with a protocol for clinical escalation if vital sign alert thresholds are exceeded.

Sponsors & Collaborators

• Medtronic

  collaborator INDUSTRY

• Providence Health Care Ventures

  collaborator UNKNOWN

• Cloud DX Inc.

  collaborator INDUSTRY

• Excelar

  collaborator UNKNOWN

• 3D Bridge Solutions

  collaborator UNKNOWN

• Simon Fraser University

  collaborator OTHER

• Providence Health & Services

  collaborator OTHER

• University of British Columbia

  lead OTHER

Principal Investigators

• Janny Ke, MD · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-17

Primary Completion

2027-02-28

Completion

2027-12-31

Countries

• Canada

Study Locations