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Evaluation of CNAP During Anesthesia (CnapEval)

This study has been terminated.
(Difficulty to include more patients)
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01032226
First received: December 12, 2009
Last updated: March 19, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to compare

  • the non invasive measurement of arterial pressure (CNAP monitor)
  • with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia

Condition
General Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of CNAP During Induction and Maintenance of General Anesthesia

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Comparison between both methods of arterial pressure measurement [ Time Frame: intraoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • cardiac arrhythmias,
  • history of vascular surgery or vascular implant in the upper limb
  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: NCT01032226

Locations
France
Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

No publications provided

Responsible Party: Dr Marc Fischler, Hôpital Foch
ClinicalTrials.gov Identifier: NCT01032226     History of Changes
Other Study ID Numbers: 2009/03
Study First Received: December 12, 2009
Last Updated: March 19, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on November 24, 2014