Intraoperative Pleth Variability Index (PVI) Variability

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03215238

Enrollment

Registered

2017-07-12

Start date

2017-10-01

Completion date

2018-11-30

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Monitoring

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PVI variability	1 hour	PVI variability will be compare to raw infrared photoplethysmography signal

Countries

United States

Outcome results