AnesthesiaNCT03120910
Pleth Variability Index (PVI) to Predict Fluid Responsiveness
A study testing Pulse CO-Oximeter Sensor in people with Anesthesia, run by Masimo Corporation at 1 site in United States.
Trial summary
Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Pulse CO-Oximeter Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2016to 9 Feb 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
- Arterial line and Swan-Ganz catheter placement indicated as part of the scheduled surgical procedure
Who cannot join
- Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish, or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study
- Patients with cardiac arrhythmias
- Patients with intracardiac shunts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of PVI as a Parameter to Predict Fluid Responsiveness
Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV).
Read the detailed description
No subjects were enrolled into the validation portion of this study.
- Conditions
- Anesthesia
- Being tested
- Pulse CO-Oximeter Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse CO-Oximeter SensorDevice
Investigational Pulse Oximeter Sensor will measure hemoglobin (SpHb), pulse rate (PR), perfusion index (PI), pleth variability index (PVI), oxygen reserve index (ORI), etc.
| Study group | Role | What they receive |
|---|---|---|
| Test Subjects | Experimental | All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensor, including nasal sensors, with the same or similar technology and materials as the Masimo FDA cleared devices and sensors. Receives: Device: Pulse CO-Oximeter Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical utility of PVI
Correlation between PVI and SVV to assess PVI as a predictor for fluid responsiveness.
Measured: 1-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start15 Dec 2016
- Primary completion9 Feb 2018
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120910
- Sponsor's protocol ID
- FLEM0005
- Status last verified
- Dec 2020
- First submitted
- 14 Apr 2017
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of PVI as a Parameter to Predict Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT03120910
- Acronym / sponsor ID
- FLEM0005
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 19 Apr 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.
Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV).
Detailed description
No subjects were enrolled into the validation portion of this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Subjects | Experimental | Device: Pulse CO-Oximeter SensorAll subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensor, including nasal sensors, with the same or similar technology and materials as the Masimo FDA cleared devices and sensors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
- Arterial line and Swan-Ganz catheter placement indicated as part of the scheduled surgical procedure
Key exclusion criteria (3 listed)
- Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish, or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study
- Patients with cardiac arrhythmias
- Patients with intracardiac shunts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse CO-Oximeter SensorInvestigational Pulse Oximeter Sensor will measure hemoglobin (SpHb), pulse rate (PR), perfusion index (PI), pleth variability index (PVI), oxygen reserve index (ORI), etc. | Device | Test Subjects |
Primary outcome
Clinical utility of PVI
Time frame: 1-5 hours
Correlation between PVI and SVV to assess PVI as a predictor for fluid responsiveness.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse CO-Oximeter Sensor in people with Anesthesia, run by Masimo Corporation 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Jan 2021. 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 withdrawn before enrolling participants, so there are no results.
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?
Clinical utility of PVI (time frame: 1-5 hours). 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 5 Jan 2021.