Intraoperative MonitoringNCT03215238
Intraoperative Pleth Variability Index (PVI) Variability
An observational study of Intraoperative Monitoring, run by University of California, San Francisco at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Monitoring
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Neurosurgical patients for tumor resection
- neurointerventional patients
- general anesthesia with mechanical ventilation
- communicates in english (consent)
- over 18 years of age
Who cannot join
- unable to sign consent
- less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94122
About this study
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.
Read the 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.
- Conditions
- Intraoperative Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| neurosurgical patients | Neurosurgical patients undergoing craniotomies for tumor. 25 subjects | |
| Neurointerventional patients | Patients undergoing neurointerventional procedures under general anesthesia. 25 subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVI variability
PVI variability will be compare to raw infrared photoplethysmography signal
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Oct 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Why it stopped: enrollment too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative MonitoringStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pekka Talke, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215238
- Sponsor's protocol ID
- PT1701
- Status last verified
- Oct 2020
- First submitted
- 9 Jul 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pleth Variability Index (PVI) Variability
- ClinicalTrials.gov ID
- NCT03215238
- Acronym / sponsor ID
- PT1701
- Conditions
- Intraoperative Monitoring
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: enrollment too slow
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neurosurgical patients | – | –Neurosurgical patients undergoing craniotomies for tumor. 25 subjects |
| Neurointerventional patients | – | –Patients undergoing neurointerventional procedures under general anesthesia. 25 subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Neurosurgical patients for tumor resection
- neurointerventional patients
- general anesthesia with mechanical ventilation
- communicates in english (consent)
- over 18 years of age
Key exclusion criteria (2 listed)
- unable to sign consent
- less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PVI variability
Time frame: 1 hour
PVI variability will be compare to raw infrared photoplethysmography signal
Results and safety
The study was stopped early (reason given: enrollment too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pekka Talke, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Monitoring, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrollment too slow). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVI variability (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.