CompletedNCT01389011PI-PVIUpdated Sep 7, 2011

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

An observational study in Perfusion Index and Pleth Variability Index, Interscalene Blocks and Orthopedic Surgery, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-09-07.

Sponsored by Johannes Gutenberg University Mainz · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 30
Ages: 18 Years to 80 Years
Sex: All

Study summary

The purpose of this study is to:

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

Conditions studied

Perfusion Index and Pleth Variability Index
Interscalene Blocks
Orthopedic Surgery

Keywords

PI
PVI
Interscalene block

In context

Lead sponsor

Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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 design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 30 participants (estimated)

Study locations

1 site

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

References and documents

Publications

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. PubMed 23055034 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01389011
Lead sponsor: Johannes Gutenberg University Mainz
First posted: Jul 7, 2011
Start date: Sep 2010
Last update: Sep 7, 2011

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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