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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02717468

Acronym

CLEARSIGHT

Enrollment

Registered

2016-03-23

Start date

2016-02-29

Completion date

2017-02-28

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output Measurement

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.

Interventions

DEVICECardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026