NCT03215238

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

July 9, 2017

Last Update Submit

October 15, 2020

Conditions

Intraoperative Monitoring

Outcome Measures

Primary Outcomes (1)

  • PVI variability

    PVI variability will be compare to raw infrared photoplethysmography signal

    1 hour

Study Arms (2)

neurosurgical patients

Neurosurgical patients undergoing craniotomies for tumor. 25 subjects

Neurointerventional patients

Patients undergoing neurointerventional procedures under general anesthesia. 25 subjects

Eligibility Criteria

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

Neurosurgical and neurointerventional patients will be enrolled as these patients do rarely have sudden intravascular volume changes. Neurointerventional patients typically have no significant intravascular fluid changes, but do not routinely have intra-arterial catheters. Neurosurgical patients have slow, steady fluid shifts due to mannitol administration. Since most all of these patients have intra-arterial cannulas, it allows arterial waveform data collection which can be compared to the PPG signal.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94122, United States

Location

Study Officials

  • Pekka Talke, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2017

First Posted

July 12, 2017

Study Start

October 1, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)