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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01732133
First received: November 19, 2012
Last updated: April 10, 2017
Last verified: April 2017
  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: No masking
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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: November 19, 2012
Last Updated: April 10, 2017

Keywords provided by Hopital Foch:
Hypotension
Cesarean delivery

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2017