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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Output Measurement
• Intervention / Treatment: Device: Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®); Device: Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • Matthieu BOISSON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Stroke Ejection Volume (SEV) measure by ClearSight®	24 hours
Stroke Ejection Volume (SEV) measure by Pulsioflex®	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac Output (CO) measure by ClearSight®	24 hours
Cardiac Output (CO) measure by Pulsioflex®	24 hours
Stroke Ejection Volume Variations (SVV) measure by ClearSight®	24 hours
Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®	24 hours

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2015-A01895-44