Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications
- Conditions
- Complication, Postoperative
- Interventions
- Device: Continuous wireless monitoring
- Registration Number
- NCT02957825
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 747
- Adult patients undergoing acute or elective major or intermediate surgery
- American Society of Anesthesiology (ASA) score of I to IV
- Inability to give written and informed consent
- Refusal to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous wireless monitoring Continuous wireless monitoring Continuous wireless monitoring
- Primary Outcome Measures
Name Time Method Disability-free survival 3 months Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire
- Secondary Outcome Measures
Name Time Method In-hospital mortality within 30 days Patient died during the initial hospital stay
Comprehensive Complication Index score (CCI) within 30 days or until hospital discharge, whatever comes first The CCI is an assessment tool for a patient's overall morbidity based on the number and severity of complications
Quality of life as measured by EuroQoL questionnaire 3 months EuroQol Dutch EQ-5D-5L
90 day mortality 90 days Did the patient die 90 days after the operation
Disability-free survival 1 month Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire
Patient Health Status 3 months Short-Form Health Survey; SF-12, Dutch version
Length of hospital stay within 30 days or until hospital discharge, whatever comes first Admission to discharge
30 day mortality 30 days Did the patient die 30 days after the operation
ICU admission within 30 days or until hospital discharge, whatever comes first ICU admission and length of stay in ICU
Total number of complications within 30 days or until hospital discharge, whatever comes first Total number of complications (as mentioned in the surgical discharge letter, based on the Clavien-Dindo classification) per 100 patients grated in severity
Number of patients with one or more complications (also from the surgical discharge letter) within 30 days or until hospital discharge, whatever comes first Incidence of postoperative complications
Trial Locations
- Locations (2)
Academic Medical Center, University of Amsterdam
🇳🇱Amsterdam, Netherlands
University Medical Center Utrecht (UMCU)
🇳🇱Utrecht, Netherlands