Clinical trial NCT06584825: Enhanced Vitals Monitoring After Major Surgery Trial
Official title: Impact of Enhanced Postoperative Vitals Monitoring In-hospital and At Home Vs. Existing In-hospital Monitoring for Medium- to High-risk Patients Undergoing Inpatient Major Abdominal and Vascular Surgery: a Pilot Single-centre RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery
Post Operative Complications
Quality of Recovery
General Surgery
Vascular Surgery
Urology
Gynecology
Keywords: Days alive and at home
DAH30
Quality of Recovery 15
Pilot Randomized Controlled Trial
vitals
blood pressure
heart rate
oxygen saturation
device
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Providence Health Care Ventures
name: Cloud DX Inc.
name: Excelar
name: 3D Bridge Solutions
name: Simon Fraser University
name: Providence Health & Services
First posted: 2024-09-05
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot single-centre randomized controlled study
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Days Alive At Home (DAH30)
timeFrame: Within 30 days after surgery, with the day of surgery as day 0
Secondary outcomes:
measure: Major Morbidity
timeFrame: Within 30 days after surgery, with the day of surgery as day 0
measure: Mortality
timeFrame: Within 30 days after surgery, with the day of surgery as day 0
measure: Emergency Department visit(s) after discharge
timeFrame: Within 30 days after surgery, with the day of surgery as day 0
measure: Readmission(s)
timeFrame: Within 30 days after surgery, with the day of surgery as day 0
measure: Urgent walk-in clinic visit(s)
timeFrame: Within 30 days after surgery, with the day of surgery as day 0
measure: Family doctor clinic visit(s)
timeFrame: Within 30 days after surgery, with the day of surgery as day 0
measure: Surgeon clinic contact(s)
timeFrame: Within 30 days after surgery, with the day of surgery as day 0
measure: Post-Operative Length of Stay
timeFrame: The time from the date of the surgery to the date of discharge from the hospital, up to 30 days after surgery
measure: Quality of Recovery at 10 days postoperatively
timeFrame: 10 days after surgery
measure: Quality of Recovery at 30 days postoperatively
timeFrame: 30 days after surgery with the day of surgery as day 0
Other outcomes:
measure: Completion of the intervention
timeFrame: 30 days after surgery with the day of surgery as day 0
measure: Participant Recruitment Rate
timeFrame: Preoperatively, at the time of recruitment, up to 1 month prior to surgery.
measure: Participant Exclusion Rate
timeFrame: Preoperatively, at the time of screening and recruitment, up to 1 month prior to surgery.
measure: Participant Withdrawal Rate
timeFrame: Preoperatively, at the time of recruitment, up to 30 days post-operatively
measure: Participant patterns of use of monitoring devices
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: Device issues encountered
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: Reasons for device removal
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: Interruptions in vitals monitoring
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: In-Hospital Enhanced Monitoring Device System Usability Scale
timeFrame: At the time of discharge from hospital, from 2 to 30 days postoperatively
measure: At-Home Enhanced Monitoring Device System Usability Scale
timeFrame: 30 days after surgery, with the day of surgery as day 0
measure: Care escalation frequency
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: Response time
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: Logistics of Enhanced Monitoring Implementation
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: Workflow Issues
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: Adverse Events
timeFrame: Up to 30 days after surgery, with the day of surgery as day 0
measure: Patient Feedback
timeFrame: 30 days after surgery, with the day of surgery as day 0
measure: Study Costs
timeFrame: Pre-study and up to time of publication
measure: Questionnaire Completion
timeFrame: From time of enrollment to 30 days after surgery with the day of surgery as day 0
measure: Method of Questionnaire Completion
timeFrame: From time of enrollment to 30 days after surgery with the day of surgery as day 0
measure: Support needed for questionnaires
timeFrame: From time of enrollment to 30 days after surgery with the day of surgery as day 0
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Janny Ke, MD
role: PRINCIPAL_INVESTIGATOR
References: