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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01732133
First received: November 19, 2012
Last updated: January 7, 2014
Last verified: January 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 7, 2014
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 July 23, 2014