Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications Using Continuing Wireless Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 747
- Locations
- 2
- Primary Endpoint
- Disability-free survival
Study Overview
Brief Summary
The aim of this study is to test the hypothesis that continuous wireless monitoring on the postsurgical ward will improve patient outcome, measured as disability-free survival at three months after surgery. Further, the investigators hypothesize that this tight control regimen decreases length of hospital stay and treatment costs in patients with complications.
Detailed Description
Every year, approximately 1,500,000 surgical procedures are performed in The Netherlands alone. After major surgery, the complication rate is conservatively estimated at 25%, with a rate of 15% for major complications. In these patients, the most important problems are a failure to timely detect developing complications and a failure to adequately rescue those patients. Currently, measurement of vital signs and standardized assessment of patient wellbeing are routinely performed intermittently for every 8-12 hours, which may lead to a failure to detect of patients with complications.
The aim of this study is to test the hypothesis that continuous wireless monitoring on the postsurgical ward will improve patient outcome, measured as disability-free survival at three months after surgery. Further, the investigators hypothesize that this tight control regimen decreases length of hospital stay and treatment costs in patients with complications.
The investigators will carry out this study as an interventional, randomized (per surgical ward), prospective, clinical trial; participating wards will be included using a stepped-wedge design.
Primary outcome is disability-free survival at three months after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients undergoing acute or elective major or intermediate surgery
- •American Society of Anesthesiology (ASA) score of I to IV
Exclusion Criteria
- •Inability to give written and informed consent
- •Refusal to participate
Outcomes
Primary Outcomes
Disability-free survival
Time Frame: 3 months
Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire
Secondary Outcomes
- Quality of life as measured by EuroQoL questionnaire(3 months)
- 90 day mortality(90 days)
- In-hospital mortality(within 30 days)
- Comprehensive Complication Index score (CCI)(within 30 days or until hospital discharge, whatever comes first)
- Disability-free survival(1 month)
- Patient Health Status(3 months)
- Length of hospital stay(within 30 days or until hospital discharge, whatever comes first)
- 30 day mortality(30 days)
- ICU admission(within 30 days or until hospital discharge, whatever comes first)
- Total number of complications(within 30 days or until hospital discharge, whatever comes first)
- Number of patients with one or more complications (also from the surgical discharge letter)(within 30 days or until hospital discharge, whatever comes first)
Investigators
B Preckel
Professor of Anesthesiology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)