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

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ClinicalTrials.gov Identifier: NCT02957825
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
B Preckel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment Phase
Complication, Postoperative Device: Continuous wireless monitoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1892 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
No Intervention: Control
Routine monitoring
Experimental: Continuous wireless monitoring
Continuous wireless monitoring
Device: Continuous wireless monitoring
Continuous wireless monitoring of vital signs




Primary Outcome Measures :
  1. Disability-free survival [ Time Frame: 3 months ]
    Disability-free survival as measured by the World Health Organization Disability After Survery (WHODAS) 2.0 questionnaire



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957825


Contacts
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Contact: Benedikt Preckel, MD +31 20 566 ext 2162 b.preckel@amc.uva.nl

Locations
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Netherlands
Academic Medical Center, University of Amsterdam Recruiting
Amsterdam, Netherlands
Contact: Benedikt Preckel, MD PhD    +31 20 566 ext 2533    b.preckel@amc.uva.nl   
University Medical Center Utrecht (UMCU) Not yet recruiting
Utrecht, Netherlands
Contact: Cor Kalkman, MD PhD    +31 88 755 ext 5555    c.j.kalkman@umcutrecht.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
Investigators
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Principal Investigator: Benedikt Preckel, MD Academic Medical Centyer Amsterdam, Anesthesiology

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Responsible Party: B Preckel, Professor of Anesthesiology, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02957825     History of Changes
Other Study ID Numbers: SHEPHERD
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes