Enhanced Vitals Monitoring After Major Surgery Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia

About 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 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.

Eligibility criteria

Qualifiers

Undergoing inpatient major abdominal (general surgery, urology, or gynecology) or vascular surgery at St. Paul's Hospital (SPH) and Mount Saint Joseph (MSJ) Hospital

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

Living within British Columbia, Canada and in an area that is covered by Bell cellular network (the Cloud DX Inc. device has cellular Long Term Evolution (LTE) using the Bell network).

Disqualifiers

Patient refusal

Transplant surgery, since these patients have a unique set of considerations and postoperative course.

Inability to communicate with research personnel, perform self-monitoring of vital signs, or complete study surveys due to cognitive, language, visual, or hearing barriers

Lack of capacity to consent to the study (including under the active influence of sedative medication or having received general anesthetic within the past 24 hours)

Trial design

Treatments tested in this trial

  • Enhanced Vitals Monitoring

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of British Columbia

Lead sponsor

Medtronic

Collaborator

Providence Health Care Ventures

Collaborator

Cloud DX Inc.

Collaborator

Excelar

Collaborator

3D Bridge Solutions

Collaborator

Simon Fraser University

Collaborator

Providence Health & Services

Collaborator