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SurgeryNCT06584825

Enhanced Vitals Monitoring After Major Surgery Trial

A study testing Enhanced Vitals Monitoring in people with Surgery and Post Operative Complications, run by University of British Columbia at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Enhanced Vitals Monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesCanada
Study dates
17 Nov 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 9Show fewer
  • 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.)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Janny Ke, MD contact

604-816-3339

janny.ke@ubc.ca

Canada2 sites, 2 recruiting
  • Mount Saint Joseph's Hospital

    Vancouver, British Columbia, V5T 3N4

    Nicola Edwards, 604-682-2344 ext. 62115, nicola.edwards@phc.ca

    Recruiting
  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Nicola Edwards, MHA, 604-861-9024, nedwards@providencehealth.bc.ca

    Janny Xue Chen Ke, MD

    Recruiting

Other trials in Canada

About this study

Official title: The Impact of Enhanced Postoperative Vitals Monitoring In-hospital and at Home vs. Standard Care After Inpatient Abdominal and Vascular Surgery: A Pilot Two-centre Randomized Controlled Study

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.

Read the detailed description

After surgeries, patients are at risk of a variety of complications, thus requiring monitoring for early detection and treatment of complications. The current standard of care consists of continuous monitoring of vital signs during and after anesthetic and/or in the high-acuity and intensive care units, followed by intermittent measurement of vital signs once the patient is in the ward. Once the patient is at home, there is no monitoring nor follow-up.

However, it has been well-established that existing intermittent monitoring of vital signs are too infrequent to capture important vital sign derangements. For example, in an observational study of 312 patients who underwent abdominal surgery, 18% of patients had blood pressure <65 mmHg for at least 15 minutes that were not detected by conventional intermittent monitoring. Nevertheless, it remains unknown the optimal method and duration of increased monitoring for medium-to-high risk surgical patients in-hospital and at home. In a randomized controlled trial (RCT) involving 905 adults undergoing non-elective surgery, remote automated monitoring with virtual care did not reduce the number of days alive and at home 30 days after surgery (DAH30) compared to standard of care. However, there are signals of increased detection of drug errors, decreased pain, and benefits in patients in centres with more escalations in care.

This study is a single-blinded, parallel-group, pilot RCT, with an exploratory feasibility analysis. The study will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) pilot RCT standards.

The study will be conducted at St Paul's Hospital (SPH), Providence Health Care (PHC), in Vancouver, British Columbia, Canada, an academic tertiary care hospital affiliated with the University of British Columbia. The study will also run at and Mount Saint Joseph's (MSJ) Hospital, PHC. The PHC anesthesia and surgical program already has a strong perioperative care focus, featuring enhanced postoperative support available for high risk patients including 1) surgical high-acuity unit (SHAU) with continuous monitoring, run by anesthesiologists, 2) Perioperative Outreach Team that rounds on patients daily for as long as clinically indicated, run by anesthesiologists, 3) multidisciplinary collaboration and support from perioperative internal medicine and/or geriatric teams, with daily rounding for as long as clinically indicated and availability for preoperative consultation and post-discharge follow-up in rapid access clinics, and 4) protocolized monitoring for myocardial injury after non-cardiac surgery for three days according to the Canadian Cardiovascular Society guidelines.

The objective of the study is to obtain pilot data on the enhanced monitoring of vital signs in patients undergoing inpatient major abdominal and/or vascular surgery (i.e. continuous monitoring of vital signs in-hospital (from the day of surgery until 3 days after surgery) followed by twice-daily monitoring at home for 3 days after discharge, with a protocol for care escalation if needed, compared to standard monitoring (intermittent monitoring in-hospital and no monitoring at home).

Being tested
Enhanced Vitals Monitoring
Keywords
Days alive and at home, DAH30, Quality of Recovery 15, Pilot Randomized Controlled Trial, vitals, blood pressure, heart rate, oxygen saturation, device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Vitals MonitoringDevice

    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.

Study groups in NCT06584825
Study groupRoleWhat they receive
Enhanced Vitals MonitoringExperimentalEnhanced (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.
Receives: Device: Enhanced Vitals Monitoring
Standard CareNo interventionStandard 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (11)
  1. 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.

    Measured: 14 days after surgery

  2. 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

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

  3. Mortality

    All cause mortality within 30 days of surgery

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

  4. 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.

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

  5. Readmission(s)

    This outcome describes if a participant was readmitted to hospital after initial discharge from hospital within 30 days of surgery, and if so, for how long and how many times.

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

  6. Urgent walk-in clinic visit(s)

    This outcome describes if a participant visited an urgent walk-in clinic after discharge within 30 days of surgery, and if so, a count of how many times.

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

  7. Family doctor clinic visit(s)

    This outcome describes if a participant visited a family doctor clinic after discharge within 30 days of surgery, and if so, a count of how many times. This will include details of planned (for suture/staple removal, or other reason) vs. unplanned

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

  8. Surgeon clinic contact(s)

    This outcome describes if a participant visited their surgeon after discharge within 30 days of surgery, and if so, a count of how many times. This will also include details of whether it was a planned (for suture/staple removal, or other reason) vs. unplanned visit and an email, phone call or clinic visit.

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

  9. Post-Operative Length of Stay

    The amount of time a patient is in hospital after their operation.

    Measured: The time from the date of the surgery to the date of discharge from the hospital, up to 30 days after surgery

  10. Quality of Recovery at 14 days postoperatively

    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.

    Measured: 14 days after surgery

  11. Quality of Recovery at 30 days postoperatively

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2024
  2. Study start17 Nov 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A pilot two-centre randomized controlled study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06584825
Sponsor's protocol ID
H23-03640
Status last verified
Nov 2025
First submitted
29 Aug 2024
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Vitals Monitoring in people with Surgery and Post Operative Complications, run by University of British Columbia at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janny Ke, MD (604-816-3339, janny.ke@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days Alive At Home (DAH30) (time frame: Within 30 days after surgery, with the day of surgery as day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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