Validation of PVI in Tidal Volume Challenge TestNCT04978909
PVI for TVC Response
An observational study of Validation of PVI in Tidal Volume Challenge Test, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Determine the ability of changes in Plethysmographic Variability Index during tidal volume challenge to predict fluid responsiveness Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Validation of PVI in Tidal Volume Challenge Test
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2021to Jul 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective major surgery (estimated > 2-hr) with general anesthesia and mechanical ventilation in supine position
Who may be able to join
- Patients undergoing elective major surgery (estimated > 2-hr) with general anesthesia and mechanical ventilation in supine position
Who cannot join
- BMI < 18.5 or >30 kg/m2
- Pregnant patient
- Allergy to starch solution
- estimated glomerular filtration rate< 60
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chun-Yu Wu, 0972653376, longersolo@gmail.com
About this study
Official title: The Effectiveness of Tidal Volume Challenge Incorporating Plethysmographic Variability Index in Predicting Fluid Responsiveness
Determine the ability of changes in Plethysmographic Variability Index during tidal volume challenge to predict fluid responsiveness
Read the detailed description
The change of Plethysmographic Variability Index after tidal volume challenge as a predictor of fluid responsiveness, confirmed with the change of SVV using Flotrac advance cardiac output monitor.
To determine whether the patient is fluid responder, Fluid challenge will be performed afterwards to confirm the patient's fluid responsiveness.
We also aim to calculate the least significant change for Plethysmographic Variability Index and Philips PPV system.
- Keywords
- tidal volume challenge,Plethysmography variability index,Fluid responsiveness
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive ability of change in Plethysmographic Variability Index after Tidal volume challenge to predict fluid responsiveness
The change in value of Plethysmographic Variability Index after increasing VTE from 6 ml/kg to 8 ml/kg.
Measured: 20 minutes
Secondary outcomes (1)
Least significant change for Massimo PVI and Philips PPV
Calculate the least significant change for Massimo PVI and Philips PPV using data acquired from our electronic system
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of PVI in Tidal Volume Challenge TestStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978909
- Sponsor's protocol ID
- 202104002RINC
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Tidal Volume Challenge Incorporating Plethysmographic Variability Index in Predicting Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT04978909
- Acronym / sponsor ID
- 202104002RINC
- Keywords
- tidal volume challenge,Plethysmography variability index,Fluid responsiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 27 Jul 2021 (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.
Determine the ability of changes in Plethysmographic Variability Index during tidal volume challenge to predict fluid responsiveness
Detailed description
The change of Plethysmographic Variability Index after tidal volume challenge as a predictor of fluid responsiveness, confirmed with the change of SVV using Flotrac advance cardiac output monitor.
To determine whether the patient is fluid responder, Fluid challenge will be performed afterwards to confirm the patient's fluid responsiveness.
We also aim to calculate the least significant change for Plethysmographic Variability Index and Philips PPV system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective major surgery (estimated > 2-hr) with general anesthesia and mechanical ventilation in supine position
Key inclusion criteria (1 listed)
- Patients undergoing elective major surgery (estimated > 2-hr) with general anesthesia and mechanical ventilation in supine position
Key exclusion criteria (4 listed)
- BMI < 18.5 or >30 kg/m2
- Pregnant patient
- Allergy to starch solution
- estimated glomerular filtration rate< 60
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
The predictive ability of change in Plethysmographic Variability Index after Tidal volume challenge to predict fluid responsiveness
Time frame: 20 minutes
The change in value of Plethysmographic Variability Index after increasing VTE from 6 ml/kg to 8 ml/kg.
1 secondary outcome
Least significant change for Massimo PVI and Philips PPV
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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.
Chun-Yu Wu principal investigator
National Taiwan University Hospital
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 Validation of PVI in Tidal Volume Challenge Test, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jul 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yu Wu (0972653376, longersolo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive ability of change in Plethysmographic Variability Index after Tidal volume challenge to predict fluid responsiveness (time frame: 20 minutes). 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 27 Jul 2021.