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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01732133

Acronym

NEXFIN-CESAR

Enrollment

171

Registered

2012-11-22

Start date

2013-04-30

Completion date

2016-01-22

Last updated

2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Hypotension, Cesarean delivery

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.

Interventions

DEVICENexfin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison between Nexfin and intermittent measurements of blood pressure	two years	Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth

Secondary

Measure	Time frame	Description
Area under the curve between both measurements	two years	Analysis concerns data from intrathecal injection to childbirth

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026