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

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

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.

Study Overview

• Status: Terminated
• Conditions: Complication, Postoperative
• Intervention / Treatment: Device: Continuous wireless monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 747
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Center, University of Amsterdam
  • Utrecht, Netherlands
    • University Medical Center Utrecht (UMCU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Routine monitoring
Experimental: Continuous wireless monitoring	Device: Continuous wireless monitoring; Continuous wireless monitoring of vital signs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: UMC Utrecht
• Investigators: Principal Investigator: Benedikt Preckel, MD, Academic Medical Centyer Amsterdam, Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimated): November 8, 2016

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: SHEPHERD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No