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

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Terminated

Conditions

Complication, Postoperative

Treatments

Device: Continuous wireless monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT02957825
SHEPHERD

Details and patient eligibility

About

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.

Full 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.

Enrollment

747 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

747 participants in 2 patient groups

Control
No Intervention group
Description:
Routine monitoring
Continuous wireless monitoring
Experimental group
Description:
Continuous wireless monitoring
Treatment:
Device: Continuous wireless monitoring

Trial contacts and locations

2

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Central trial contact

Benedikt Preckel, MD

Data sourced from clinicaltrials.gov

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