Complication, Postoperative
Conditions
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.
Interventions
DEVICEContinuous wireless monitoring
Continuous wireless monitoring of vital signs
Sponsors
UMC Utrecht
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability-free survival | 3 months | Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life as measured by EuroQoL questionnaire | 1 month | EuroQol Dutch EQ-5D-5L |
| Patient Health Status | 1 month | 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 |
| In-hospital mortality | within 30 days | Patient died during the initial hospital stay |
| 30 day mortality | 30 days | Did the patient die 30 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 |
| 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 |
| 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 |
| ICU admission | within 30 days or until hospital discharge, whatever comes first | ICU admission and length of stay in ICU |
| 90 day mortality | 90 days | Did the patient die 90 days after the operation |
Countries
Netherlands
Outcome results
None listed