Venous; Return (Anomaly)RPVINCT03572894
Comparison of PVI and RPVI
An observational study of Venous; Return (Anomaly), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pleth Variability Index (PVI) is a non-invasive and automated measure of the respiratory variations of plethysmography during mechanical ventilation. PVI is extracted via an algorithm implemented on Masimo Radical 7 device (Masimo, Irvine, CA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous; Return (Anomaly)
- What is being tested?
- PVI and RPVI measurements
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2018to 27 Sep 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
- Adult, Older adult
Study population: All adult patients undergoing closed-chest surgery in the supine position under general anaesthesia.
Who may be able to join
- Age > 18
- Low or intermediate risk surgery or noninvasive procedures in the supine position
- General anaesthesia and volume-controlled mechanical ventilation.
Who cannot join
- Non sinus heart rhythm
- Left Ventricular Ejection Fraction < 50%
- Documented right ventricle failure
- Lack of patient consent
- Pregnancy
- Minor patient or under tutorship
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- Presence of spontaneous ventilatory movements (attested by a real respiratory rate higher than the set respiratory rate)
- Report HR / RR <3.6 (HR: heart rate, RR: respiratory rate)
- Open chest surgery
- Laparoscopic surgery
- Vital or lateral decubitus surgery
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie Réanimation, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon
Bron, 69394
About this study
Official title: Comparison of PVI and RPVI During a Tidal Volume Challenge Under General Anesthesia: A Prospective Validation Pilot Study
Pleth Variability Index (PVI) is a non-invasive and automated measure of the respiratory variations of plethysmography during mechanical ventilation. PVI is extracted via an algorithm implemented on Masimo Radical 7 device (Masimo, Irvine, CA). PVI is commonly used in anesthesiology and has been validated to predict fluid responsiveness and optimize fluid administration in the surgical setting. However, the signal/noise ratio of PVI makes acute changes in PVI somewhat difficult to interpret at the bedside. Subsequently, a new algorithm entitled RPVI (Rainbow Pleth Variability Index), has been developed in order to improve the signal/noise ratio of PVI and facilitate its clinical use by practitioners. The details of this new proprietary built-in algorithm are unknown and no data are available to date. Therefore, the main objective of the study was to compare RPVI and PVI during dynamic changes in venous return induced by a tidal volume (Vt) challenge during mechanical ventilation in anesthetized patients. The hypothesis was that the agreement between both dynamic indices would be good.
- Conditions
- Venous; Return (Anomaly)
- Being tested
- PVI and RPVI measurements
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI and RPVI measurementsDevice
PVI and RPVI measurements during variations of the tidal volume (Vt challenge) and a recruitment maneuver in anesthetized and mechanically ventilated patients.
- T0 : Vt 6 mL/kg of predicted body weight (PBW) during 5 minutes
- T1 : Vt 8 mL/Kg of PBW during 5 minutes
- T2 : Vt 10 mL/kg of PBW during 5 minutes
- T3 : Vt 6 mL/kg of PBW during 5 minutes
- T4 : A single recruitment maneuver
Data will be recorded at each step.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diagnostic characteristics of RPVI in comparison to PVI
Agreement and interchangeability of RPVI and PVI: Bland Altman analysis for repeated measurements
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start25 Jul 2018
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous; Return (Anomaly)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572894
- Sponsor's protocol ID
- 69HCL18_0313
- Acronym
- RPVI
- Status last verified
- Jun 2018
- First submitted
- 19 Jun 2018
- Last updated
- 5 Dec 2018
- 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 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PVI and RPVI During a Tidal Volume Challenge Under General Anesthesia: A Prospective Validation Pilot Study
- ClinicalTrials.gov ID
- NCT03572894
- Acronym / sponsor ID
- RPVI / 69HCL18_0313
- Conditions
- Venous; Return (Anomaly)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 28 Jun 2018 (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 non-invasive and automated measure of the respiratory variations of plethysmography during mechanical ventilation. PVI is extracted via an algorithm implemented on Masimo Radical 7 device (Masimo, Irvine, CA). PVI is commonly used in anesthesiology and has been validated to predict fluid responsiveness and optimize fluid administration in the surgical setting. However, the signal/noise ratio of PVI makes acute changes in PVI somewhat difficult to interpret at the bedside. Subsequently, a new algorithm entitled RPVI (Rainbow Pleth Variability Index), has been developed in order to improve the signal/noise ratio of PVI and facilitate its clinical use by practitioners. The details of this new proprietary built-in algorithm are unknown and no data are available to date. Therefore, the main objective of the study was to compare RPVI and PVI during dynamic changes in venous return induced by a tidal volume (Vt) challenge during mechanical ventilation in anesthetized patients. The hypothesis was that the agreement between both dynamic indices would be good.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing closed-chest surgery in the supine position under general anaesthesia.
Key inclusion criteria (3 listed)
- Age > 18
- Low or intermediate risk surgery or noninvasive procedures in the supine position
- General anaesthesia and volume-controlled mechanical ventilation.
Key exclusion criteria (11 listed)
- Non sinus heart rhythm
- Left Ventricular Ejection Fraction < 50%
- Documented right ventricle failure
- Lack of patient consent
- Pregnancy
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 |
|---|---|---|
| PVI and RPVI measurementsPVI and RPVI measurements during variations of the tidal volume (Vt challenge) and a recruitment maneuver in anesthetized and mechanically ventilated patients. * T0 : Vt 6 mL/kg of predicted body weight (PBW) during 5 minutes * T1 : Vt 8 mL/Kg of PBW during 5 minutes * T2 : Vt 10 mL/kg of PBW during 5 minutes * T3 : Vt 6 mL/kg of PBW during 5 minutes * T4 : A single recruitment maneuver Data will be recorded at each step. | Device | – |
Primary outcome
Evaluation of the diagnostic characteristics of RPVI in comparison to PVI
Time frame: 30 minutes
Agreement and interchangeability of RPVI and PVI: Bland Altman analysis for repeated measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: No
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?
An observational study of Venous; Return (Anomaly), run by Hospices Civils de Lyon at 1 site in France.
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 11 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: finished, as of the sponsor's last update on 5 Dec 2018. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the diagnostic characteristics of RPVI in comparison to PVI (time frame: 30 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 5 Dec 2018.