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.
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).
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)
Parallel
Enhanced Vitals Monitoring
DeviceFor 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.
Days Alive At Home (DAH30)
Number of days within 30 days of surgery when participants are alive and at home, without visiting an emergency department or urgent care centre or being admitted to a hospital. Home refers to their own home, or a residence of a relative, friend or acquaintance, but excludes a nursing home or a rehabilitation facility. If a participant visits an emergency department or urgent care centre, or is admitted to a hospital any time between midnight and 23:59 on a given day, they will lose that day as a day alive at home. If they remain in the care facility past midnight into the next day, then they lose 2 days alive at home. They will continue to lose days alive at home until the day in which they are home from midnight for an entire day. In other words, a day alive at home can be counted only when participants spend an entire day from midnight to 23:59 at home, without being stay at an emergency department, an urgent-care centre or a hospital.
Quality of Recovery at baseline
Measured using the Quality of Recovery-15 (QoR-15) score. QoR-15 scale is a validated tool to assess the quality of postoperative recovery. It consists of 15 likert questions in two parts. Part A consists of 10 questions asking a patient how they have been feeling in the previous 24 hours with regards to factors such as sleeping and eating. Responses are given on an 11 point likert scale from 0 to 10, where 0 is none of the time \[poor\] and 10 is all of the time \[excellent\]. Part B consists of five questions which ask the patient if they have experienced specific adverse events (for example, pain, nausea/vomiting or anxiety). Responses are given on an 11 point likert scale from 10 to 0, where 10 is none of the time \[excellent\] and 0 is all of the time \[poor\]. This questionnaire is administered either over the phone, online or on paper.
Major Morbidity
Complications associated with 30-day mortality: major bleeding, myocardial injury after noncardiac surgery (includes myocardial infarction), myocardial infarction (3rd Universal Definition), sepsis, infection without sepsis, acute kidney injury with new dialysis, stroke, venous thromboembolism and congestive heart failure) within 30 days postoperatively
Mortality
All cause mortality within 30 days of surgery
Emergency Department visit(s) after discharge
This outcome describes if a participant visited an emergency department after discharge within 30 days of surgery, and if so, a count of how many times.
Completion of the intervention
The primary feasibility outcome is defined as more than 80% of participants completing the monitoring protocol, with a priori definition of the completion being monitoring in-hospital and at home each for 3 times a day for 3 days (or the duration of the hospital stay, whichever is shorter).
Participant Recruitment Rate
The proportion of patients recruited who provided consent out of all meeting the clinical inclusion criteria
Participant Exclusion Rate
The proportion of patients excluded out of all patients screened
Participant Withdrawal Rate
The proportion of patients who withdrew from the study out of all enrolled patients.
Click on the lead sponsor to view all of their trials.
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
