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

NCT ID: NCT01658631

Last Updated: 2016-11-03

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

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anesthesia

Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during the induction of anesthesia

arterial pressure measurement (Nexfin, a noninvasive finger cuff system)

Intervention Type DEVICE

Intensive Care Unit patients

Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during a passive legs raising test

arterial pressure measurement (Nexfin, a noninvasive finger cuff system)

Intervention Type DEVICE

Interventions

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arterial pressure measurement (Nexfin, a noninvasive finger cuff system)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Mutualiste Montsouris

Paris, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

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France

References

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Weiss E, Gayat E, Dumans-Nizard V, Le Guen M, Fischler M. Use of the Nexfin device to detect acute arterial pressure variations during anaesthesia induction. Br J Anaesth. 2014 Jul;113(1):52-60. doi: 10.1093/bja/aeu055. Epub 2014 Apr 25.

Reference Type DERIVED
PMID: 24771806 (View on PubMed)

Other Identifiers

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2010-A00881-38

Identifier Type: OTHER

Identifier Source: secondary_id

2010/42

Identifier Type: -

Identifier Source: org_study_id