110 Participants Needed

Enhanced Vitals Monitoring for Surgery

Recruiting at 1 trial location
JK
NE
Overseen ByNicola Edwards, MHA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether enhanced monitoring devices can improve recovery after certain surgeries. It focuses on patients undergoing medium- to high-risk vascular or abdominal surgeries to determine if more frequent vital sign checks can increase the number of days spent at home in the first month post-surgery. Participants will use special devices to monitor their vitals both in the hospital and at home. This trial may suit those having these surgeries at St. Paul’s Hospital, who expect to stay in the hospital for at least two days and can use the devices at home. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgical recovery for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this enhanced vitals monitoring is safe for surgical patients?

Research shows that using wearable devices to closely monitor vital signs can make surgery recovery safer. Studies have found that continuous tracking of health signals helps reduce complications for patients. This method monitors important health indicators and quickly alerts doctors if something is wrong.

Health Canada has approved the devices used for this monitoring, confirming they meet safety standards. Patients in earlier studies used these devices without any serious side effects. Overall, evidence suggests that this type of monitoring is a safe way to potentially improve recovery after surgery.12345

Why are researchers excited about this trial?

Researchers are excited about Enhanced Vitals Monitoring because it offers a more comprehensive way to track patients' health after surgery compared to standard care. Unlike the usual monitoring done only in hospitals, this method uses Health Canada-approved devices for continuous monitoring at home, three times a day, for up to 30 days post-surgery. This enhanced monitoring can quickly alert medical teams if vital signs reach critical levels, potentially leading to faster interventions and better patient outcomes.

What evidence suggests that enhanced vitals monitoring is effective for post-operative management?

In this trial, participants will join one of two groups. The Enhanced Vitals Monitoring group will receive enhanced monitoring using Health Canada-approved devices in the hospital, followed by thrice-daily monitoring at home for up to 30 days postoperatively. Previous studies have shown that continuous vital sign tracking in a hospital improved certain health measures and reduced complications for surgery patients. Research indicates that advanced monitoring devices can detect potential issues early, leading to better recovery after surgery. For patients healing from surgery, continuous monitoring has enhanced safety and quality of care. Early findings suggest that improved monitoring can help maintain patient health and may shorten hospital stays, potentially allowing more time at home in the first month after surgery.23467

Who Is on the Research Team?

JK

Janny Ke, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for adults in British Columbia, Canada who are having medium- to high-risk vascular or abdominal surgery at St. Paul's Hospital and expect to stay there for at least 48 hours. They should be able to read and speak English (or have a caregiver who can) and live in an area with Bell cellular network coverage.

Inclusion Criteria

I am scheduled for inpatient vascular or abdominal surgery at St. Paul's Hospital, excluding transplant surgery.
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
See 2 more

Exclusion Criteria

I can communicate and perform self-monitoring without any barriers.
Unable to use (or does not have a caregiver who can help put on/take off) study monitoring device at home
Patient with known allergic reactions to any part material of the device
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Monitoring

Participants undergo major abdominal or vascular surgery with continuous monitoring of vital signs in-hospital

Up to 30 days postoperatively
Continuous in-hospital monitoring

Enhanced Monitoring

Participants in the intervention group receive enhanced monitoring using devices in-hospital and thrice-daily at home for up to 30 days postoperatively

Up to 30 days postoperatively
Thrice-daily monitoring at home

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up phone call and questionnaire

30 days after surgery
1 follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Vitals Monitoring
Trial Overview Researchers are testing if enhanced vital sign monitoring both in the hospital and at home after surgery can improve recovery outcomes compared to standard care. Participants will use two different devices for monitoring their vitals and answer questionnaires, with a follow-up call.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Vitals MonitoringExperimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

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Citations

Continuous Vital Sign Monitoring at the Surgical Ward for ...Meaning: Continuous monitoring in the postoperative ward improves specific physiological parameters and reduces adverse events. Despite the ...
Enhanced Vitals Monitoring After Major Surgery TrialThe aim of this clinical trial is to examine the feasibility of an enhanced vital sign monitoring solution in-hospital and at-home.
Continuous vital sign monitoring of patients recovering ...This review summarises the history of general ward monitoring and describes future directions, including opportunities to implement these devices using ...
Enhanced Vitals Monitoring for Surgery · Info for ParticipantsResearchers will compare the enhanced vitals monitoring group to the standard of care group to see if it may change post-operative management and outcomes.
Enhancing Quadruple Health Outcomes After Thoracic SurgeryThis pilot RCT demonstrates the feasibility of conducting a full-scale trial to assess DHM's efficacy in improving postoperative care following thoracic ...
Enhanced monitoring for postoperative hospital wardsContinuous ward monitoring with wearable devices holds significant promise in improving patient safety and outcomes.
Continuous Vital Sign Monitoring at the Surgical Ward for...Meaning: Continuous monitoring in the postoperative ward improves specific physiological parameters and reduces adverse events. Despite the recent decades' ...
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