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Completed

NCT Number: NCT02717468

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

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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 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

Treatment and study plan

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®).

Device

Primary outcomes

  1. Stroke Ejection Volume (SEV) measure by ClearSight®

    Time frame: 24 hours

  2. Stroke Ejection Volume (SEV) measure by Pulsioflex®

    Time frame: 24 hours

Secondary outcomes

  1. Cardiac Output (CO) measure by ClearSight®

    Time frame: 24 hours

  2. Cardiac Output (CO) measure by Pulsioflex®

    Time frame: 24 hours

  3. Stroke Ejection Volume Variations (SVV) measure by ClearSight®

    Time frame: 24 hours

  4. Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: CLEARSIGHT

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 23, 2016
Registry last updated
May 18, 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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