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

This study has been completed.
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01389011
First received: July 5, 2011
Last updated: September 6, 2011
Last verified: July 2011
  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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01389011

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

No publications provided by Johannes Gutenberg University Mainz

Additional 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
Study First Received: July 5, 2011
Last Updated: September 6, 2011
Health Authority: Germany: ethics committee Rheinland-Pfalz

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

ClinicalTrials.gov processed this record on July 23, 2014