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NCT01732133 Clinical Trial

Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension

Hypotension Clinical Trial

— NEXFIN-CESAR  

Official title:
Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01732133
Other study ID # 2012/27
Secondary ID 2012-A00811-42
Status Completed
Phase N/A
First received November 19, 2012
Last updated April 10, 2017
Start date April 2013
Est. completion date January 22, 2016

Study information
Verified date April 2017
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.

Recruitment information / eligibility
Status Completed
Enrollment 171
Est. completion date January 22, 2016
Est. primary completion date January 22, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Nexfin

Locations
Country Name City State
France Institut Hospitalier Franco-Britannique Levallois
France Hopital Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison between Nexfin and intermittent measurements of blood pressure Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth two years
Secondary Area under the curve between both measurements Analysis concerns data from intrathecal injection to childbirth two years
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