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OpenTrials
Completed

NCT Number: NCT01732133

Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension

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

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Hospitalier Franco-Britannique, Levallois-Perret, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nexfin

Device

Other names: Continuous measurement of arterial pressure using Nexfin

Primary outcomes

  1. 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

  1. Area under the curve between both measurements

    Time frame: two years

    Analysis concerns data from intrathecal injection to childbirth

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: NEXFIN-CESAR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 22, 2012
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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