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

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ClinicalTrials.gov Identifier: NCT01732133
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

November 19, 2012
November 22, 2012
April 11, 2017
April 2013
January 22, 2016   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01732133 on ClinicalTrials.gov Archive Site
Area under the curve between both measurements [ Time Frame: two years ]
Analysis concerns data from intrathecal injection to childbirth
Same as current
Not Provided
Not Provided
 
Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Hypotension
Device: Nexfin
Other Name: Continuous measurement of arterial pressure using Nexfin
Experimental: Measurement of arterial pressure
Intervention: Device: Nexfin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
200
January 22, 2016
January 22, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01732133
2012/27
2012-A00811-42 ( Other Identifier: ANSM )
No
Not Provided
Not Provided
Hopital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hopital Foch
Hopital Foch
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP