Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications Using Continuing Wireless Monitoring

Conditions
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Complication, Postoperative

Intervention / Treatment
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* Device: Continuous wireless monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Routine monitoring | |
| Experimental: Continuous wireless monitoring<br>Continuous wireless monitoring | Device: Continuous wireless monitoring<br>* Continuous wireless monitoring of vital signs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability-free survival | Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability-free survival | Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire | 1 month | 
| Quality of life as measured by EuroQoL questionnaire | EuroQol Dutch EQ-5D-5L | 1 month | 
| Quality of life as measured by EuroQoL questionnaire | EuroQol Dutch EQ-5D-5L | 3 months | 
| Patient Health Status | Short-Form Health Survey; SF-12, Dutch version | 1 month | 
| Patient Health Status | Short-Form Health Survey; SF-12, Dutch version | 3 months | 
| Length of hospital stay | Admission to discharge | within 30 days or until hospital discharge, whatever comes first | 
| In-hospital mortality | Patient died during the initial hospital stay | within 30 days | 
| 30 day mortality | Did the patient die 30 days after the operation | 30 days | 
| 90 day mortality | Did the patient die 90 days after the operation | 90 days | 
| Total number of complications | Total number of complications (as mentioned in the surgical discharge letter, based on the Clavien-Dindo classification) per 100 patients grated in severity | within 30 days or until hospital discharge, whatever comes first | 
| Number of patients with one or more complications (also from the surgical discharge letter) | Incidence of postoperative complications | within 30 days or until hospital discharge, whatever comes first | 
| Comprehensive Complication Index score (CCI) | The CCI is an assessment tool for a patient's overall morbidity based on the number and severity of complications | within 30 days or until hospital discharge, whatever comes first | 
| ICU admission | ICU admission and length of stay in ICU | within 30 days or until hospital discharge, whatever comes first |