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Clinical Trials/NCT01732133
NCT01732133
Completed
Not Applicable

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

Hopital Foch2 sites in 1 country171 target enrollmentApril 2013
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ConditionsHypotension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypotension
Sponsor
Hopital Foch
Enrollment
171
Locations
2
Primary Endpoint
Comparison between Nexfin and intermittent measurements of blood pressure
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
January 22, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Area under the curve between both measurements(two years)

Study Sites (2)

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