Cardiovascular SystemSUPRA-PAMNCT02791984
Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness
A study testing Fluid challenge with 250 ml of Ringer Lactate in people with Cardiovascular System, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Respiratory changes in aortic blood velocity have been described as an indicator of fluid responsiveness when measured in the left ventricular outflow tract by trans esophageal echography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular System
- What is being tested?
- Fluid challenge with 250 ml of Ringer Lactate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Mar 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years
- American Society of Anesthesiologists (ASA) score 1 or 2
- General Anesthesia with mechanical ventilation
- General Surgery
Who cannot join
- Arrhythmia
- Spontaneous breathing activity
- Significant valvular disease
Trial locations and contacts
1 site in 1 country.
About this study
Respiratory changes in aortic blood velocity have been described as an indicator of fluid responsiveness when measured in the left ventricular outflow tract by trans esophageal echography. A threshold value of 12% allowed discrimination between responders and nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is already used to measure cardiac output. The primary endpoint of this study is to determine the predictive value of the respiratory variability in aortic blood velocity measured by suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint is to compare maximum velocity and velocity time integral measured by suprasternal and transthoracic view.
- Conditions
- Cardiovascular System
- Being tested
- Fluid challenge with 250 ml of Ringer Lactate
- Keywords
- Suprasternal, echography, fluid responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challenge with 250 ml of Ringer LactateDevice
Fluid challenge with 250 ml of Ringer Lactate over less than 2 minutes, intra-venous, help by a syringe of 50 ml.
Measure of peak velocity before and after the fluid challenge
| Study group | Role | What they receive |
|---|---|---|
| Fluid challenge with 250 ml of Ringer Lactate | Experimental | Not described Receives: Device: Fluid challenge with 250 ml of Ringer Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cardiac flow variability
Percentage of cardiac flow variability between the 2 echographic measures. Echographic measures will be realized a first time before fluid challenge by suprasternal view and a second time after the fluid challenge by suprasternal view.
Measured: At day 1(before surgery)
Secondary outcomes (1)
Comparison of percentage of cardiac flow variability between transthoracic and suprasternal views
Echographic measures will be realized a first time before fluid challenge by transthoracic and by suprasternal view and a second time after the fluid challenge by transthoracic and by suprasternal view.
Measured: At day 1(before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SystemStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Devauchelle, MD, Principal investigator, Hopital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791984
- Sponsor's protocol ID
- 69HCL14-0408
- Acronym
- SUPRA-PAM
- Status last verified
- May 2016
- First submitted
- 27 May 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT02791984
- Acronym / sponsor ID
- SUPRA-PAM / 69HCL14-0408
- Conditions
- Cardiovascular System
- Keywords
- Suprasternal, echography, fluid responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Jun 2016 (estimated)
- 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.
Respiratory changes in aortic blood velocity have been described as an indicator of fluid responsiveness when measured in the left ventricular outflow tract by trans esophageal echography. A threshold value of 12% allowed discrimination between responders and nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is already used to measure cardiac output. The primary endpoint of this study is to determine the predictive value of the respiratory variability in aortic blood velocity measured by suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint is to compare maximum velocity and velocity time integral measured by suprasternal and transthoracic view.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid challenge with 250 ml of Ringer Lactate | Experimental | Device: Fluid challenge with 250 ml of Ringer Lactate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than 18 years
- American Society of Anesthesiologists (ASA) score 1 or 2
- General Anesthesia with mechanical ventilation
- General Surgery
Key exclusion criteria (3 listed)
- Arrhythmia
- Spontaneous breathing activity
- Significant valvular disease
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 |
|---|---|---|
| Fluid challenge with 250 ml of Ringer LactateFluid challenge with 250 ml of Ringer Lactate over less than 2 minutes, intra-venous, help by a syringe of 50 ml. Measure of peak velocity before and after the fluid challenge | Device | Fluid challenge with 250 ml of Ringer Lactate |
Primary outcome
Percentage of cardiac flow variability
Time frame: At day 1(before surgery)
Percentage of cardiac flow variability between the 2 echographic measures. Echographic measures will be realized a first time before fluid challenge by suprasternal view and a second time after the fluid challenge by suprasternal view.
1 secondary outcome
Comparison of percentage of cardiac flow variability between transthoracic and suprasternal views
Time frame: At day 1(before surgery)
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 7 Jun 2016.
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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.
Pauline Devauchelle, MD principal investigator
Hopital de la Croix-Rousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid challenge with 250 ml of Ringer Lactate in people with Cardiovascular System, 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 4 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: finished, as of the sponsor's last update on 7 Jun 2016. 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?
Percentage of cardiac flow variability (time frame: At day 1(before surgery)). 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 7 Jun 2016.