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

This study is currently recruiting participants.
Verified May 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01732133
First received: November 19, 2012
Last updated: May 19, 2013
Last verified: May 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Comparison between Nexfin and intermittent measurements of blood pressure [ Time Frame: two years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Analysis concerns data from intrathecal injection to childbirth


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732133

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, France, 92151
Contact: Marc Fischler, MD     46252442 ext 00331     m.fischler@hopital-foch.org    
Principal Investigator: Morgan LeGuen, MD            
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01732133     History of Changes
Other Study ID Numbers: 2012/27
Study First Received: November 19, 2012
Last Updated: May 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:
Hypotension
Cesarean delivery

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013