NCT01732133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2.8 years

First QC Date

November 19, 2012

Last Update Submit

April 10, 2017

Conditions

Hypotension

Keywords

HypotensionCesarean delivery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Area under the curve between both measurements

    two years

Study Arms (1)

Measurement of arterial pressure

EXPERIMENTAL
Device: Nexfin

Interventions

NexfinDEVICE
Also known as: Continuous measurement of arterial pressure using Nexfin
Measurement of arterial pressure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients undergoing elective cesarean delivery performed under spinal anesthesia

You may not qualify if:

  • patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Hospitalier Franco-Britannique

Levallois-Perret, 92300, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Related Publications (1)

  • Bobet M, Joachim J, Gayat E, Bonnet A, Sievert K, Barnichon C, Fischler M, Le Guen M. Blood pressure measurement during cesarean delivery: Evaluation of a beat-to-beat noninvasive device (NexfinTM). Medicine (Baltimore). 2021 Jun 4;100(22):e26129. doi: 10.1097/MD.0000000000026129.

    PMID: 34087863DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

April 1, 2013

Primary Completion

January 22, 2016

Study Completion

January 22, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

FR(2)