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Completed

NCT Number: NCT02941952

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

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.

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Key information

Conditions

Cardiac Output Measurement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Matthieu BOISSON

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. Stroke ejection volume (SEV) measure by ClearSight®

    Time frame: 24 hours

  2. Stroke ejection volume measure by PICCO®

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: CLEARPICCO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2016
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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