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Clinical Trials/NCT02717468
NCT02717468
Completed
Not Applicable

Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery

Poitiers University Hospital1 site in 1 country30 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Output Measurement
Sponsor
Poitiers University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Stroke Ejection Volume (SEV) measure by ClearSight®
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.

Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.

The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.

The objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
February 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled to undergo major surgery
  • Patients monitored by a Pulsioflex® device

Exclusion Criteria

  • Patients with heart rhythm disorder
  • Patients with Raynaud's disease or vasculitis
  • Emergency surgery
  • Significant edema fingers

Outcomes

Primary Outcomes

Stroke Ejection Volume (SEV) measure by ClearSight®

Time Frame: 24 hours

Stroke Ejection Volume (SEV) measure by Pulsioflex®

Time Frame: 24 hours

Secondary Outcomes

  • Cardiac Output (CO) measure by Pulsioflex®(24 hours)
  • Cardiac Output (CO) measure by ClearSight®(24 hours)
  • Stroke Ejection Volume Variations (SVV) measure by ClearSight®(24 hours)
  • Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®(24 hours)

Study Sites (1)

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