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

Cardiac Output Measurement Clinical Trial

— CLEARSIGHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717468
• Other study ID #: 2015-A01895-44
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output Measurement

Intervention

Device:
• Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®)

• Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).

Locations

Country	Name	City	State
France	Matthieu BOISSON	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke Ejection Volume (SEV) measure by ClearSight®		24 hours
Primary	Stroke Ejection Volume (SEV) measure by Pulsioflex®		24 hours
Secondary	Cardiac Output (CO) measure by ClearSight®		24 hours
Secondary	Cardiac Output (CO) measure by Pulsioflex®		24 hours
Secondary	Stroke Ejection Volume Variations (SVV) measure by ClearSight®		24 hours
Secondary	Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®		24 hours