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

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ClinicalTrials.gov Identifier: NCT02717468
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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.


Condition or disease Intervention/treatment Phase
Cardiac Output Measurement Device: 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®). Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery
Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717468


Locations
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France
Matthieu BOISSON
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02717468    
Other Study ID Numbers: 2015-A01895-44
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: October 2016