NCT01389011

Brief Summary

The purpose of this study is to:

  1. 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. 2.To compare effects of fluid-bolusing on PI and PVI of the anesthetized and non-anesthetized limb.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
Last Updated

September 7, 2011

Status Verified

July 1, 2011

First QC Date

July 5, 2011

Last Update Submit

September 6, 2011

Conditions

Perfusion Index and Pleth Variability IndexInterscalene BlocksOrthopedic Surgery

Keywords

PIPVIInterscalene block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (1)

  • Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.

    PMID: 23055034DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 7, 2011

Study Start

September 1, 2010

Last Updated

September 7, 2011

Record last verified: 2011-07

Locations

DE(1)