Clinical trial NCT02957825: Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications
Official title: Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications Using Continuing Wireless Monitoring
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complication, Postoperative
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
First posted: 2016-11-08
Enrollment: 747
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Disability-free survival
timeFrame: 3 months
Secondary outcomes:
measure: Disability-free survival
timeFrame: 1 month
measure: Quality of life as measured by EuroQoL questionnaire
timeFrame: 1 month
measure: Quality of life as measured by EuroQoL questionnaire
timeFrame: 3 months
measure: Patient Health Status
timeFrame: 1 month
measure: Patient Health Status
timeFrame: 3 months
measure: Length of hospital stay
timeFrame: within 30 days or until hospital discharge, whatever comes first
measure: In-hospital mortality
timeFrame: within 30 days
measure: 30 day mortality
timeFrame: 30 days
measure: 90 day mortality
timeFrame: 90 days
measure: Total number of complications
timeFrame: within 30 days or until hospital discharge, whatever comes first
measure: Number of patients with one or more complications (also from the surgical discharge letter)
timeFrame: within 30 days or until hospital discharge, whatever comes first
measure: Comprehensive Complication Index score (CCI)
timeFrame: within 30 days or until hospital discharge, whatever comes first
measure: ICU admission
timeFrame: within 30 days or until hospital discharge, whatever comes first
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht (UMCU)
Study officials:
affiliation: Academic Medical Centyer Amsterdam, Anesthesiology
name: Benedikt Preckel, MD
role: PRINCIPAL_INVESTIGATOR
References: