NCT02717468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 18, 2018

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

February 18, 2016

Last Update Submit

May 15, 2018

Conditions

Cardiac Output Measurement

Outcome Measures

Primary Outcomes (2)

  • Stroke Ejection Volume (SEV) measure by ClearSight®

    24 hours

  • Stroke Ejection Volume (SEV) measure by Pulsioflex®

    24 hours

Secondary Outcomes (4)

  • Cardiac Output (CO) measure by ClearSight®

    24 hours

  • Cardiac Output (CO) measure by Pulsioflex®

    24 hours

  • Stroke Ejection Volume Variations (SVV) measure by ClearSight®

    24 hours

  • Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®

    24 hours

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo major surgery
  • Patients monitored by a Pulsioflex® device

You may not qualify if:

  • Patients with heart rhythm disorder
  • Patients with Raynaud's disease or vasculitis
  • Emergency surgery
  • Significant edema fingers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matthieu BOISSON

Poitiers, 86021, France

Location

MeSH Terms

Interventions

Cardiac Output

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 23, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

May 18, 2018

Record last verified: 2016-10

Locations

FR(1)