Enhanced Vitals Monitoring After Major Surgery Trial

Launched by UNIVERSITY OF BRITISH COLUMBIA · Sep 2, 2024

Keywords

ClinConnect Summary

The Enhanced Vitals Monitoring After Major Surgery Trial is a study designed to see if using special devices to monitor vital signs can help patients recover better after major surgery. This trial will involve adults who are having medium- to high-risk vascular or abdominal surgeries at St. Paul's Hospital. The goal is to find out if enhanced monitoring can lead to more days spent at home and fewer complications in the first month after surgery, compared to standard care. Participants will use two monitoring devices—one while in the hospital and another at home—and will be asked to fill out some questionnaires and have a follow-up phone call.

To be eligible for this trial, participants must be having a planned stay in the hospital for at least 48 hours and be considered medium- to high-risk for complications. They should also be comfortable reading and speaking English and live in an area in British Columbia, Canada, that has the right cellular network for the monitoring devices. It’s important to note that some people may not be able to participate, such as those who cannot communicate effectively or have certain medical conditions. Overall, this study aims to improve how we manage recovery after surgery and help patients feel better at home.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Undergoing inpatient vascular surgery or abdominal surgery (general surgery, gynecology, and urology, except transplant surgery) at St. Paul's Hospital
• • 2. 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
• • 3. Medium- to high-risk patient, as defined by postoperative 30-day mortality 2% or greater as predicted preoperatively by the SORT criteria, the best performing model amongst existing models (http://www.sortsurgery.com/index.php?)
• • 4. Self-reported fluency in reading and speaking in English for patient or home caregiver
• • 5. 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).
• Exclusion Criteria:
• • 1. Patient refusal
• • 2. Inability to communicate with research personnel, perform self-monitoring of vital signs, or complete study surveys due to cognitive, language, visual, or hearing barriers
• • 3. 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)
• • 4. Unable to use (or does not have a caregiver who can help put on/take off) study monitoring device at home
• • 5. Preoperatively known planned discharge to a nursing home or rehabilitation facility
• • 6. Patient with known allergic reactions to any part material of the device
• • 7. Unable to monitor blood pressure accurately noninvasively using arm blood pressure cuffs, such as due to underlying vascular anatomy or non-pulsatile blood flow physiology
• • 8. Transplant surgery, since these patients have a unique set of considerations and postoperative course.