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

Poitiers University Hospital

Status: Completed

Conditions: Cardiac Output Measurement

Treatments: 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

Funder types: Other

Identifiers

NCT02717468

2015-A01895-44

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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