Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications (SHEPHERD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02957825|
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Complication, Postoperative||Device: Continuous wireless monitoring||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1892 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications Using Continuing Wireless Monitoring|
|Actual Study Start Date :||February 2, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
No Intervention: Control
Experimental: Continuous wireless monitoring
Continuous wireless monitoring
Device: Continuous wireless monitoring
Continuous wireless monitoring of vital signs
- Disability-free survival [ Time Frame: 3 months ]Disability-free survival as measured by the World Health Organization Disability After Survery (WHODAS) 2.0 questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957825
|Contact: Benedikt Preckel, MD||+31 20 566 ext email@example.com|
|Academic Medical Center, University of Amsterdam||Recruiting|
|Contact: Benedikt Preckel, MD PhD +31 20 566 ext 2533 firstname.lastname@example.org|
|University Medical Center Utrecht (UMCU)||Not yet recruiting|
|Contact: Cor Kalkman, MD PhD +31 88 755 ext 5555 email@example.com|
|Principal Investigator:||Benedikt Preckel, MD||Academic Medical Centyer Amsterdam, Anesthesiology|