Intraoperative Pleth Variability Index (PVI) Variability

Intraoperative Monitoring Clinical Trial

Official title:

Intraoperative Pleth Variability Index (PVI) Variability

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03215238
• Other study ID #: PT1701
• Status: Terminated
• Start date: October 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Monitoring

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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