Recruiting

Enhanced Vitals Monitoring

Sponsor:

University of British Columbia

Code:

NCT06584825

Conditions

Surgery

Post Operative Complications

Quality of Recovery

General Surgery

Vascular Surgery

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Enhanced Vitals Monitoring

Study Details

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

Study ID

NCT06584825

Start date

Nov 17, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Undergoing inpatient major abdominal (general surgery, urology, or gynecology) or vascular surgery at St. Paul's Hospital (SPH) and Mount Saint Joseph (MSJ) 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. Self-reported fluency in reading and speaking in English for patient or home caregiver
4. 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. Transplant surgery, since these patients have a unique set of considerations and postoperative course.
3. Inability to communicate with research personnel, perform self-monitoring of vital signs, or complete study surveys due to cognitive, language, visual, or hearing barriers
4. 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)
5. Unable to use (or does not have a caregiver who can help put on/take off) study monitoring device at home
6. Preoperatively known planned discharge to a nursing home or rehabilitation facility
7. Patient with known allergic reactions to any part material of the device
8. 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
9. Unlikely to be able to return the home monitoring kit (no fixed address, living too far away from site, etc.)

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Enhanced Vitals Monitoring

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.

no intervention: Standard Care

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

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.

Primary outcome measure

  • Days Alive At Home (DAH30) [ Time Frame: Within 30 days after surgery, with the day of surgery as day 0 ]

Central Contacts and Locations

Central contacts

Janny Ke, MD

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

Nicola Edwards, MHA

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

Locations

Mount Saint Joseph's Hospital

Recruiting

Vancouver, British Columbia, Canada, V5T 3N4

Contacts

Nicola Edwards

604-682-2344nicola.edwards@phc.ca

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Nicola Edwards, MHA

604-861-9024nedwards@providencehealth.bc.ca

Principal Investigator:

Janny Xue Chen Ke, MD

More Information

Sponsor

University of British Columbia

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-11-21.