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Clinical Trials/NCT03215238
NCT03215238
Terminated
Not Applicable

Intraoperative Pleth Variability Index (PVI) Variability

University of California, San Francisco1 site in 1 country10 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intraoperative Monitoring
Sponsor
University of California, San Francisco
Enrollment
10
Locations
1
Primary Endpoint
PVI variability
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

Pleth Variability Index (PVI) is a variable that is derived from photoplethysmography (PPG) signal. It is used as a surrogate for intravascular volume status intraoperatively. PVI can have significant amount of baseline variability which appears to oscillate at a very low frequency (5-10 minute cycles). This study aims to investigate the origin of these baseline oscillations.

Detailed Description

PVI is derived from the infrared photoplethysmography signal. Intraoperatively during mechanical ventilation it reflect fluid responsiveness which is a surrogate endpoint of intravascular volume. PVI signal appears to have significant baseline variability which can not be explained by rapid changes in intravascular fluid volume. The baseline PVI changes also appear to oscillate at a very low frequency, much below any previously identified spontaneous vascular oscillations. The aim of this study is to investigate weather the PVI variability originates from changes in the infrared photoplethysmography signal or if they are possibly due to the algorithm calculating PVI.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
November 30, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Neurosurgical patients for tumor resection
  • neurointerventional patients
  • general anesthesia with mechanical ventilation
  • communicates in english (consent)
  • over 18 years of age

Exclusion Criteria

  • unable to sign consent
  • less than 18 years of age

Outcomes

Primary Outcomes

PVI variability

Time Frame: 1 hour

PVI variability will be compare to raw infrared photoplethysmography signal

Study Sites (1)

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