search
Back to results

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

Primary Purpose

Complication, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Continuous wireless monitoring
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Complication, Postoperative

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Center, University of AmsterdamRecruiting
  • University Medical Center Utrecht (UMCU)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Continuous wireless monitoring

Arm Description

Routine monitoring

Continuous wireless monitoring

Outcomes

Primary Outcome Measures

Disability-free survival
Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire

Secondary Outcome Measures

Disability-free survival
Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire
Quality of life as measured by EuroQoL questionnaire
EuroQol Dutch EQ-5D-5L
Quality of life as measured by EuroQoL questionnaire
EuroQol Dutch EQ-5D-5L
Patient Health Status
Short-Form Health Survey; SF-12, Dutch version
Patient Health Status
Short-Form Health Survey; SF-12, Dutch version
Length of hospital stay
Admission to discharge
In-hospital mortality
Patient died during the initial hospital stay
30 day mortality
Did the patient die 30 days after the operation
90 day mortality
Did the patient die 90 days after the operation
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
Number of patients with one or more complications (also from the surgical discharge letter)
Incidence of postoperative complications
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
ICU admission
ICU admission and length of stay in ICU

Full Information

First Posted
September 26, 2016
Last Updated
August 19, 2020
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
UMC Utrecht
search

1. Study Identification

Unique Protocol Identification Number
NCT02957825
Brief Title
Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications
Acronym
SHEPHERD
Official Title
Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications Using Continuing Wireless Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
UMC Utrecht

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication, Postoperative

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1892 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine monitoring
Arm Title
Continuous wireless monitoring
Arm Type
Experimental
Arm Description
Continuous wireless monitoring
Intervention Type
Device
Intervention Name(s)
Continuous wireless monitoring
Intervention Description
Continuous wireless monitoring of vital signs
Primary Outcome Measure Information:
Title
Disability-free survival
Description
Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Disability-free survival
Description
Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire
Time Frame
1 month
Title
Quality of life as measured by EuroQoL questionnaire
Description
EuroQol Dutch EQ-5D-5L
Time Frame
1 month
Title
Quality of life as measured by EuroQoL questionnaire
Description
EuroQol Dutch EQ-5D-5L
Time Frame
3 months
Title
Patient Health Status
Description
Short-Form Health Survey; SF-12, Dutch version
Time Frame
1 month
Title
Patient Health Status
Description
Short-Form Health Survey; SF-12, Dutch version
Time Frame
3 months
Title
Length of hospital stay
Description
Admission to discharge
Time Frame
within 30 days or until hospital discharge, whatever comes first
Title
In-hospital mortality
Description
Patient died during the initial hospital stay
Time Frame
within 30 days
Title
30 day mortality
Description
Did the patient die 30 days after the operation
Time Frame
30 days
Title
90 day mortality
Description
Did the patient die 90 days after the operation
Time Frame
90 days
Title
Total number of complications
Description
Total number of complications (as mentioned in the surgical discharge letter, based on the Clavien-Dindo classification) per 100 patients grated in severity
Time Frame
within 30 days or until hospital discharge, whatever comes first
Title
Number of patients with one or more complications (also from the surgical discharge letter)
Description
Incidence of postoperative complications
Time Frame
within 30 days or until hospital discharge, whatever comes first
Title
Comprehensive Complication Index score (CCI)
Description
The CCI is an assessment tool for a patient's overall morbidity based on the number and severity of complications
Time Frame
within 30 days or until hospital discharge, whatever comes first
Title
ICU admission
Description
ICU admission and length of stay in ICU
Time Frame
within 30 days or until hospital discharge, whatever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benedikt Preckel, MD
Phone
+31 20 566
Ext
2162
Email
b.preckel@amc.uva.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedikt Preckel, MD
Organizational Affiliation
Academic Medical Centyer Amsterdam, Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center, University of Amsterdam
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedikt Preckel, MD PhD
Phone
+31 20 566
Ext
2533
Email
b.preckel@amc.uva.nl
Facility Name
University Medical Center Utrecht (UMCU)
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cor Kalkman, MD PhD
Phone
+31 88 755
Ext
5555
Email
c.j.kalkman@umcutrecht.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs