Enhanced vitals monitoring after major surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-blinded, parallel-group pilot randomized controlled trial will randomize adults undergoing major abdominal or vascular inpatient surgery to enhanced vitals monitoring or standard care. Participants in the intervention arm will use one continuous monitoring device in hospital and a second device at home, complete questionnaires, and receive a follow-up phone call. The primary outcome is days alive and at home within 30 days after surgery (DAH30), with exploratory feasibility analyses and assessments of detection of complications and effects on post-operative management. The trial is conducted at St. Paul's and Mount Saint Joseph hospitals in Vancouver and enrolls patients who expect a hospital stay of at least 48 hours and live within Bell cellular coverage in British Columbia.

Why it matters

Who can join: the full rules

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.)

Where it's running

• Mount Saint Joseph's Hospital
  Vancouver, British Columbia, Canada Recruiting
• St. Paul's Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Janny Ke, MD — University of British Columbia
• Study coordinator: Janny Ke, MD
• Email: janny.ke@ubc.ca
• Phone: 604-816-3339

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.