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

NCT ID: NCT02941952

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-28

Study Completion Date

2018-05-07

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Output Measurement

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Matthieu BOISSON

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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2016-A01283-48

Identifier Type: -

Identifier Source: org_study_id

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