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

September 6, 2011 updated by: Johannes Gutenberg University Mainz

An Evaluation of PI and PVI (Masimo) in Patients With Interscalene Blocks in Orthopedic Surgery

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Department of Anesthesiology, Johannes Gutenberg-University Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for surgery of the shoulder and the upper arm.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AS_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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