Evaluation of Nexfin During Anesthesia and in Intensive Care (NexfinEval)

November 2, 2016 updated by: Hopital Foch

Evaluation of Nexfin During Induction of General Anesthesia and in Intensive Care During a Passive Legs Raising Test

The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)

  • during induction of general anesthesia,
  • during a leg raising test in the Intensive Care Unit

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Suresnes, France, 92151
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing major surgery with the need for an invasive blood pressure measurement and ICU patients requiring a passive legs raising test

Description

Inclusion Criteria:

  • Age >18
  • ASA II, III or IV
  • weight between 40 and 180 kg; BMI < 35
  • normal Allen's test and/or hand Doppler examination.

Exclusion Criteria:

  • cardiac arrhythmias,
  • history of vascular surgery or vascular implant in the upper limb
  • Raynaud disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anesthesia
Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during the induction of anesthesia
Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)
Intensive Care Unit patients
Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during a passive legs raising test
Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arterial pressure measurement
Time Frame: Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes
Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 2, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2010/42
  • 2010-A00881-38 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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