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

Complication, Postoperative Clinical Trial

— SHEPHERD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02957825
• Other study ID #: SHEPHERD
• Status: Terminated
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 747
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication, Postoperative
• Postoperative Complications

Intervention

Device:
• Continuous wireless monitoring
Continuous wireless monitoring of vital signs

Locations

Country	Name	City	State
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam
Netherlands	University Medical Center Utrecht (UMCU)	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability-free survival	Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire	3 months
Secondary	Disability-free survival	Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire	1 month
Secondary	Quality of life as measured by EuroQoL questionnaire	EuroQol Dutch EQ-5D-5L	1 month
Secondary	Quality of life as measured by EuroQoL questionnaire	EuroQol Dutch EQ-5D-5L	3 months
Secondary	Patient Health Status	Short-Form Health Survey; SF-12, Dutch version	1 month
Secondary	Patient Health Status	Short-Form Health Survey; SF-12, Dutch version	3 months
Secondary	Length of hospital stay	Admission to discharge	within 30 days or until hospital discharge, whatever comes first
Secondary	In-hospital mortality	Patient died during the initial hospital stay	within 30 days
Secondary	30 day mortality	Did the patient die 30 days after the operation	30 days
Secondary	90 day mortality	Did the patient die 90 days after the operation	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	ICU admission	ICU admission and length of stay in ICU	within 30 days or until hospital discharge, whatever comes first