NCT02941952

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 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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

October 20, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

October 28, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2018

Completed
Last Updated

May 16, 2018

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

October 20, 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 measure by PICCO®

    24 hours

Interventions

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

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled to undergo major abdominal surgery
  • Patients monitored by a PICCO® 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 21, 2016

Study Start

October 28, 2016

Primary Completion

May 7, 2018

Study Completion

May 7, 2018

Last Updated

May 16, 2018

Record last verified: 2017-06

Locations

FR(1)