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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01658631
First received: August 1, 2012
Last updated: January 12, 2014
Last verified: December 2013
  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

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658631

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact: Christian Lamer, MD    56616263 ext 00331    christian.lamer@imm.fr   
Principal Investigator: Christian Lamer, MD         
Hopital Foch Recruiting
Suresnes, France, 92151
Contact: Marc Fischler, MD    46252442 ext 00331    m.fischler@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch
  More Information

No publications provided by Hopital Foch

Additional 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
Study First Received: August 1, 2012
Last Updated: January 12, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014