Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension

NCT ID: NCT01732133

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Measurement of arterial pressure

Group Type EXPERIMENTAL

Nexfin

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nexfin

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Continuous measurement of arterial pressure using Nexfin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc Fischler, MD

Role: STUDY_CHAIR

Hopital Foch

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Hospitalier Franco-Britannique

Levallois-Perret, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34087863 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-A00811-42

Identifier Type: OTHER

Identifier Source: secondary_id

2012/27

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.