- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02941952
Comparative Noninvasive Continuous Cardiac Output by the Clearsight® With Invasive Monitoring by PICCO® in Abdominal Major Surgery (CLEARPICCO)
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 transpulmonary thermodilution and the arterial waveform analysis in the radial artery by PICCO®.
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®). This continuous monitoring of blood pressure 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 transpulmonary thermodilution and the arterial waveform analysis in radial artery by PICCO® in abdominal major surgery.
Study Overview
Status
Conditions
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Poitiers, France, 86021
- Matthieu BOISSON
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients scheduled to undergo major abdominal surgery
- Patients monitored by a PICCO® 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?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stroke ejection volume (SEV) measure by ClearSight®
Time Frame: 24 hours
|
24 hours
|
Stroke ejection volume measure by PICCO®
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016-A01283-48
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Clinical Trials on Cardiac output and stroke ejection volume monitoring with both ClearSight® and PICCO® in major abdominal surgery.
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