Enhanced Vitals Monitoring After Major Surgery Trial

NCT06584825 | Recruiting

• 1 other identifier: H23-03640
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Days alive and at home; DAH30; Quality of Recovery 15; Pilot Randomized Controlled Trial; vitals; blood pressure; heart rate; oxygen saturation; device

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 30 days after surgery, with the day of surgery as day 0

Secondary Outcomes (11)

• Quality of Recovery at baseline

  14 days after surgery

• Major Morbidity

  Within 30 days after surgery, with the day of surgery as day 0

• Mortality

  Within 30 days after surgery, with the day of surgery as day 0

• Emergency Department visit(s) after discharge

  Within 30 days after surgery, with the day of surgery as day 0

• Readmission(s)

  Within 30 days after surgery, with the day of surgery as day 0

Other Outcomes (20)

• Completion of the intervention

  30 days after surgery with the day of surgery as day 0

• Participant Recruitment Rate

  Preoperatively, at the time of recruitment, up to 1 month prior to surgery.

• Participant Exclusion Rate

  Preoperatively, at the time of screening and recruitment, up to 1 month prior to surgery.

Study Arms (2)

Enhanced Vitals Monitoring

EXPERIMENTAL

Enhanced (i.e. additional) monitoring using Health Canada approved devices in-hospital postoperatively, 8am to 5pm from the day of surgery until 3 days after surgery or until discharged (whichever occurs first) followed by twice-daily monitoring at home 3 days after discharge, with a protocol for clinical escalation if vital sign alert thresholds are exceeded.

Device: Enhanced Vitals Monitoring

Standard Care

NO INTERVENTION

Standard vitals monitoring in hospital and standard of care follow-up procedures once discharged home. The research team will administer a questionnaire at 14 and 30 days postoperatively and conduct a 30 day phone call follow-up.

Interventions

Enhanced Vitals Monitoring DEVICE

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.

Enhanced Vitals Monitoring

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• Unable to use (or does not have a caregiver who can help put on/take off) study monitoring device at home
• Preoperatively known planned discharge to a nursing home or rehabilitation facility
• Patient with known allergic reactions to any part material of the device
• 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
• Unlikely to be able to return the home monitoring kit (no fixed address, living too far away from site, etc.)

Sponsors & Collaborators

• University of British Columbia: lead
• 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

Study Sites (2)

Mount Saint Joseph's Hospital

Vancouver, British Columbia, V5T 3N4, Canada

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Study Officials

• Janny Ke, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janny Ke, MD

CONTACT

604-816-3339; janny.ke@ubc.ca

Nicola Edwards, MHA

CONTACT

604-816-3339; nedwards@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Clinical Assistant Professor

Model Details: A pilot two-centre randomized controlled study

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 5, 2024
• Study Start: November 17, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)