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

NCT ID: NCT02957825

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 747 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2021-08-31

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.

Conditions

Complication, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

Routine monitoring

Group Type: NO_INTERVENTION

No interventions assigned to this group

Continuous wireless monitoring

Continuous wireless monitoring

Group Type: EXPERIMENTAL

Continuous wireless monitoring

Intervention Type: DEVICE

Continuous wireless monitoring of vital signs

Interventions

Continuous wireless monitoring

Continuous wireless monitoring of vital signs

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

B Preckel

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benedikt Preckel, MD

Role: PRINCIPAL_INVESTIGATOR

Academic Medical Centyer Amsterdam, Anesthesiology

Locations

Academic Medical Center, University of Amsterdam

Amsterdam, , Netherlands

University Medical Center Utrecht (UMCU)

Utrecht, , Netherlands

Countries

Netherlands

References

Posthuma LM, Breteler MJM, Lirk PB, Nieveen van Dijkum EJ, Visscher MJ, Breel JS, Wensing CAGL, Schenk J, Vlaskamp LB, van Rossum MC, Ruurda JP, Dijkgraaf MGW, Hollmann MW, Kalkman CJ, Preckel B. Surveillance of high-risk early postsurgical patients for real-time detection of complications using wireless monitoring (SHEPHERD study): results of a randomized multicenter stepped wedge cluster trial. Front Med (Lausanne). 2024 Jan 5;10:1295499. doi: 10.3389/fmed.2023.1295499. eCollection 2023.

Reference Type: DERIVED

PMID: 38249988 (View on PubMed)

Other Identifiers

SHEPHERD

Identifier Type: -

Identifier Source: org_study_id