Enhanced Vitals Monitoring After Major Surgery Trial

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).

• Quality of Recovery at baseline [Срок оценки: 14 days after surgery]
• Major Morbidity [Срок оценки: Within 30 days after surgery, with the day of surgery as day 0]
• Mortality [Срок оценки: Within 30 days after surgery, with the day of surgery as day 0]
• Emergency Department visit(s) after discharge [Срок оценки: Within 30 days after surgery, with the day of surgery as day 0]
• Readmission(s) [Срок оценки: Within 30 days after surgery, with the day of surgery as day 0]
• Urgent walk-in clinic visit(s) [Срок оценки: Within 30 days after surgery, with the day of surgery as day 0]
• Family doctor clinic visit(s) [Срок оценки: Within 30 days after surgery, with the day of surgery as day 0]
• Surgeon clinic contact(s) [Срок оценки: Within 30 days after surgery, with the day of surgery as day 0]
• Post-Operative Length of Stay [Срок оценки: The time from the date of the surgery to the date of discharge from the hospital, up to 30 days after surgery]
• Quality of Recovery at 14 days postoperatively [Срок оценки: 14 days after surgery]
• Quality of Recovery at 30 days postoperatively [Срок оценки: 30 days after surgery with the day of surgery as day 0]