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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732133
First Posted: November 22, 2012
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  Purpose
Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.

Condition Intervention
Hypotension Device: Nexfin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Area under the curve between both measurements [ Time Frame: two years ]
    Analysis concerns data from intrathecal injection to childbirth


Enrollment: 171
Actual Study Start Date: April 2013
Study Completion Date: January 22, 2016
Primary Completion Date: January 22, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Measurement of arterial pressure Device: Nexfin
Other Name: Continuous measurement of arterial pressure using Nexfin

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT01732133


Locations
France
Institut Hospitalier Franco-Britannique
Levallois, France, 92300
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01732133     History of Changes
Other Study ID Numbers: 2012/27
2012-A00811-42 ( Other Identifier: ANSM )
First Submitted: November 19, 2012
First Posted: November 22, 2012
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Hopital Foch:
Hypotension
Cesarean delivery

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases