Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension

Not Applicable

Completed

• Conditions: Hypotension

• Registration Number: NCT01732133
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Study Start: 2013-04
• Primary Completion: 2016-01-22
• Study Completion: 2016-01-22
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Area under the curve between both measurements	two years	Analysis concerns data from intrathecal injection to childbirth

Trial Locations

Locations (2)

Institut Hospitalier Franco-Britannique; 🇫🇷 Levallois, France

Hopital Foch; 🇫🇷 Suresnes, France