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Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery (PI-PVI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01389011
First Posted: July 7, 2011
Last Update Posted: September 7, 2011
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:
Johannes Gutenberg University Mainz
  Purpose

The purpose of this study is to:

  1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after induction of general anesthesia.
  2. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and non-anesthetized limb.

Condition
Perfusion Index and Pleth Variability Index Interscalene Blocks Orthopedic Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Evaluation of PI and PVI (Masimo) in Patients With Interscalene Blocks in Orthopedic Surgery

Further study details as provided by Johannes Gutenberg University Mainz:

Estimated Enrollment: 30
Study Start Date: September 2010
  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 to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for surgery of the shoulder and the upper arm.
Criteria

Inclusion Criteria:

  • patients scheduled for shoulder or upper arm surgery
  • ASA 1-3
  • written informed consent
  • approval from the local ethics committee

Exclusion Criteria:

  • arrhythmia
  • patients suffering from severe vascular disease, coronary artery (CCS IV) disease
  • anaemia (haemoglobin < 7mg/dl)
  • patients in whom a tidal volume of 8ml/kg cannot be delivered safely
  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): NCT01389011


Locations
Germany
Department of Anesthesiology, Johannes Gutenberg-University Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Anesthesiology Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01389011     History of Changes
Other Study ID Numbers: AS_001
First Submitted: July 5, 2011
First Posted: July 7, 2011
Last Update Posted: September 7, 2011
Last Verified: July 2011

Keywords provided by Johannes Gutenberg University Mainz:
PI
PVI
Interscalene block