NCT02957825

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 747 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complication, Postoperative

Interventions

Type	Name	Description
DEVICE	Continuous wireless monitoring	Continuous wireless monitoring of vital signs

Timeline

• Start date: 2018-02-02
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2016-11-08
• Last updated: 2023-11-21

Locations

2 sites across 1 country: Netherlands