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Comparative Noninvasive Continuous Cardiac Output by the Clearsight® With Invasive Monitoring by PICCO® in Abdominal Major Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02941952
Acronym
CLEARPICCO
Enrollment
Unknown
Registered
2016-10-21
Start date
2016-10-28
Completion date
2018-05-07
Last updated
2018-05-16

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 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.

Interventions

DEVICECardiac output and stroke ejection volume monitoring with both ClearSight® and PICCO® in major abdominal surgery.

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Stroke ejection volume (SEV) measure by ClearSight®24 hours
Stroke ejection volume measure by PICCO®24 hours

Countries

France

Outcome results

None listed

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