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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658631
First Posted: August 7, 2012
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  Purpose

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

Condition Intervention
Anesthesia Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Nexfin During Induction of General Anesthesia and in Intensive Care During a Passive Legs Raising Test

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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 ]

Enrollment: 97
Study Start Date: August 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658631


Locations
France
Institut Mutualiste Montsouris
Paris, France, 75014
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01658631     History of Changes
Other Study ID Numbers: 2010/42
2010-A00881-38 ( Other Identifier: ANSM )
First Submitted: August 1, 2012
First Posted: August 7, 2012
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs