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

Not Applicable

Completed

• Conditions: Cardiac Output Measurement

• Registration Number: NCT02717468
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Status Verified: 2016-10
• Primary Completion: 2016-12
• Study Completion: 2017-02
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Stroke Ejection Volume (SEV) measure by ClearSight®	24 hours
Stroke Ejection Volume (SEV) measure by Pulsioflex®	24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Matthieu BOISSON; 🇫🇷 Poitiers, France