Enhanced Vitals Monitoring After Major Surgery Trial

Not Applicable

Not yet recruiting

• Conditions: Surgery; Post Operative Complications; Quality of Recovery; General Surgery; Vascular Surgery; Urology; Gynecology
• Interventions: Device: Enhanced Vitals Monitoring

• Registration Number: NCT06584825
• Lead Sponsor: University of British Columbia

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 medium- to high-risk 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.

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, in Vancouver, British Columbia, Canada, an academic tertiary care hospital affiliated with the University of British Columbia.The SPH 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 high-risk patients undergoing inpatient major abdominal and/or vascular surgery (i.e. continuous monitoring of vital signs in-hospital followed by thrice-daily monitoring at home 7 days after discharge, up to a maximum of 30 days postoperatively), with a protocol for care escalation if needed, compared to standard monitoring (intermittent monitoring in-hospital and no monitoring at home).

Study Timeline

• Study First Submitted: 2024-08-29
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study Start: 2024-09-03
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Undergoing inpatient vascular surgery or abdominal surgery (general surgery, gynecology, and urology, except transplant surgery) at St. Paul's 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. Medium- to high-risk patient, as defined by postoperative 30-day mortality 2% or greater as predicted preoperatively by the SORT criteria, the best performing model amongst existing models (http://www.sortsurgery.com/index.php?)
4. Self-reported fluency in reading and speaking in English for patient or home caregiver
5. 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. Inability to communicate with research personnel, perform self-monitoring of vital signs, or complete study surveys due to cognitive, language, visual, or hearing barriers
3. 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)
4. Unable to use (or does not have a caregiver who can help put on/take off) study monitoring device at home
5. Preoperatively known planned discharge to a nursing home or rehabilitation facility
6. Patient with known allergic reactions to any part material of the device
7. 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
8. Transplant surgery, since these patients have a unique set of considerations and postoperative course.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Vitals Monitoring	Enhanced Vitals Monitoring	Enhanced (i.e. additional) monitoring using Health Canada approved devices in-hospital followed by thrice-daily monitoring at home 7 days after discharge (up to a maximum of 30 days postoperatively in total), with a protocol for clinical escalation if vital sign alert thresholds are exceeded.

Primary Outcome Measures

Name	Time	Method
Days Alive At Home (DAH30)	Within 30 days after surgery, with the day of surgery as day 0	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.

Secondary Outcome Measures

Name	Time	Method
Major Morbidity	Within 30 days after surgery, with the day of surgery as day 0	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
Mortality	Within 30 days after surgery, with the day of surgery as day 0	All cause mortality within 30 days of surgery
Emergency Department visit(s) after discharge	Within 30 days after surgery, with the day of surgery as day 0	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.
Readmission(s)	Within 30 days after surgery, with the day of surgery as day 0	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.
Urgent walk-in clinic visit(s)	Within 30 days after surgery, with the day of surgery as day 0	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.
Family doctor clinic visit(s)	Within 30 days after surgery, with the day of surgery as day 0	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
Surgeon clinic contact(s)	Within 30 days after surgery, with the day of surgery as day 0	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.
Post-Operative Length of Stay	The time from the date of the surgery to the date of discharge from the hospital, up to 30 days after surgery	The amount of time a patient is in hospital after their operation.
Quality of Recovery at 10 days postoperatively	10 days after surgery	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.
Quality of Recovery at 30 days postoperatively	30 days after surgery with the day of surgery as day 0	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.

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada