Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension (NEXFIN-CESAR)

April 10, 2017 updated by: Hopital Foch

Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia

Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Levallois, France, 92300
        • Institut hospitalier franco-britannique
      • Suresnes, France, 92151
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • adult patients undergoing elective cesarean delivery performed under spinal anesthesia

Exclusion Criteria:

  • patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measurement of arterial pressure
Device: Nexfin
Other Names:
  • Continuous measurement of arterial pressure using Nexfin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between Nexfin and intermittent measurements of blood pressure
Time Frame: two years
Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve between both measurements
Time Frame: two years
Analysis concerns data from intrathecal injection to childbirth
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

January 22, 2016

Study Completion (Actual)

January 22, 2016

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 22, 2012

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/27
  • 2012-A00811-42 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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