Circulatory FailureCVCISIMPLIFIEENCT06921642
Simplified Inferior Vena Cava Collapsiblity
An observational study of Circulatory Failure, run by University Hospital, Lille at 1 site in France.
Trial summary
Fluid administration is a cornerstone therapy in critically ill patient. Fluid restriction or overload can therefore change patient's outcome and mortality. Close monitoring of PR (capacity of increase the cardiac output after fluid therapy) is recommended by experts' guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulatory Failure
- What is being tested?
- Echocardiography images
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2023to 7 Jun 2024
- 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: All patient hospitalized in an intensive care unit of the Medecine intensive center of Lille who respond to the inclusion criteria may be included in this trial
Who may be able to join
- Patient requiring an evaluation of PR by echocardiography for
- Presence of at least one clinical sign of acute circulatory failure (Mean Arterial Pressure < 65 mmHg, mottling, tachycardia with Heart Rate > 90 bpm, capillary refill time > 3 sec, oliguria (urine output < 0,5 mL/kg/h over 1 hour or more))
- Noradrenaline administration
- Age > 18 years old
- Spontaneous breathing patient requiring oxygen administration without mechanical assistance
Who cannot join
- Intolerance of inspiratory maneuver defined by:
- Clinical sign of acute respiratory failure
- Active abdominal expiration
- Hemodynamic response of passive leg raising not evaluable:
- Intracranial hypertension
- Impaired transthoracic or abdominal echogenicity
Show all 12Show fewer
- High grade aortic insufficiency
- Pregnancy
- Abdominal compartment syndrome
- Lower limb amputation
- Urgent hemodynamic therapy within half an hour
- Modification of hemodynamic support (fluid therapy or modification of catecholamine dose)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Performance of a Simplified Inferior Vena Cava Collapsibility Methodology to Predict Preload Responsiveness (PR) in Spontaneously Breathing and Critically Ill Patients"
Fluid administration is a cornerstone therapy in critically ill patient. Fluid restriction or overload can therefore change patient's outcome and mortality. Close monitoring of PR (capacity of increase the cardiac output after fluid therapy) is recommended by experts' guidelines. Few bedside simple tests are available to predict PR in spontaneously breathing patients.
A team of investigators from Lille (Roger Salengro hospital) have already showed that inferior vena cava collapsibility (cVCI) accuracy of prediction of PR is excellent in standardized sponteanous breathing patient. However, the standardized inspiration maneuver remains challenging because requiring specific and non-widely available equipment.
Read the detailed description
The primary objective of this study is to confirmed the excellent accuracy of cVCI to predict PR when standardized inspiratory maneuver is simplified.
The secondary objective is to test cVCIs in different period of cardiac cycle guided by electrocardiogram.
After receiving a loyal information patients will give their non-objection. During systematic echocardiography, patients will have to breathe in different conditions in order to homogenize their inspiratory effort. This maneuver will be repeated three times.
- Conditions
- Circulatory Failure
- Being tested
- Echocardiography images
- Keywords
- Fluid therapy, preload responsiveness, spontaneously breathing, critically ill patient, standardized inspiratory maneuver
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography imagesDevice
Addition of a recording loop during routine ultrasound, during which the patient is in simplified standardized ventilation
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing patient responding to the inclusion criteria | During a transthoracic echocardiography, the doctor will realize
* loops on inferior vena cava in different breathing conditions :
* non standardized spontaneous breathing
* simplified standardized spontaneous breathing using a TRIFLOW III spirometer device. Standardized inspiration is defined by the complete ascension of the first of the three device ball.
* deep spontaneous inspiration defined by profound inspiration during < 3 seconds without calibration of inspiratory strengh
* measure of subaortic velocity time integral (Vti) during a passive leg raising.
Inferior vena cava collapsibility index will be calculated using inferior vena cava diameter, at 4 cm from right atrium abutment, using the following equation: (Diameter max - diameter min)/ diameter max.
PR will be defined by 10% increase of Vti during passive leg raising. Receives: Device: Echocardiography images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness
the area under the ROC curve of the parameter of simplification of inspiratory effort in relation to the positive hemodynamic response positive haemodynamic response (cardiac preload-dependence) to a passive leg raising manoeuvre
Measured: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.
Secondary outcomes (2)
Performance of inferior vena cava collapsibility index during a deep breath (without monitoring of inspiratory strength) to predict preload responsiveness
comparison of the areas under the ROC curve for the parameter simplifying inspiratory effort during tele-diastole or tele-cardiac systole
Measured: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.
Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness during different time of cardiac cycle
the area under the ROC curve of the parameter of simplification of inspiratory effort in relation to the positive hemodynamic response positive haemodynamic response (cardiac preload-dependence) to a passive leg raising manoeuvre
Measured: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start6 Jun 2023
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921642
- Sponsor's protocol ID
- 2022_0324
- Acronym
- CVCISIMPLIFIEE
- Status last verified
- Apr 2025
- First submitted
- 7 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Performance of a Simplified Inferior Vena Cava Collapsibility Methodology to Predict Preload Responsiveness (PR) in Spontaneously Breathing and Critically Ill Patients"
- ClinicalTrials.gov ID
- NCT06921642
- Acronym / sponsor ID
- CVCISIMPLIFIEE / 2022_0324
- Conditions
- Circulatory Failure
- Keywords
- Fluid therapy, preload responsiveness, spontaneously breathing, critically ill patient, standardized inspiratory maneuver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 10 Apr 2025 (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.
Fluid administration is a cornerstone therapy in critically ill patient. Fluid restriction or overload can therefore change patient's outcome and mortality. Close monitoring of PR (capacity of increase the cardiac output after fluid therapy) is recommended by experts' guidelines. Few bedside simple tests are available to predict PR in spontaneously breathing patients.
A team of investigators from Lille (Roger Salengro hospital) have already showed that inferior vena cava collapsibility (cVCI) accuracy of prediction of PR is excellent in standardized sponteanous breathing patient. However, the standardized inspiration maneuver remains challenging because requiring specific and non-widely available equipment.
Detailed description
The primary objective of this study is to confirmed the excellent accuracy of cVCI to predict PR when standardized inspiratory maneuver is simplified.
The secondary objective is to test cVCIs in different period of cardiac cycle guided by electrocardiogram.
After receiving a loyal information patients will give their non-objection. During systematic echocardiography, patients will have to breathe in different conditions in order to homogenize their inspiratory effort. This maneuver will be repeated three times.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing patient responding to the inclusion criteria | – | Device: Echocardiography imagesDuring a transthoracic echocardiography, the doctor will realize * loops on inferior vena cava in different breathing conditions : * non standardized spontaneous breathing * simplified standardized spontaneous breathing using a TRIFLOW III spirometer device. Standardized inspiration is defined by the complete ascension of the first of the three device ball. * deep spontaneous inspiration defined by profound inspiration during < 3 seconds without calibration of inspiratory strengh * measure of subaortic velocity time integral (Vti) during a passive leg raising. Inferior vena cava collapsibility index will be calculated using inferior vena cava diameter, at 4 cm from right atrium abutment, using the following equation: (Diameter max - diameter min)/ diameter max. PR will be defined by 10% increase of Vti during passive leg raising. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient hospitalized in an intensive care unit of the Medecine intensive center of Lille who respond to the inclusion criteria may be included in this trial
Key inclusion criteria (5 listed)
- Patient requiring an evaluation of PR by echocardiography for
- Presence of at least one clinical sign of acute circulatory failure (Mean Arterial Pressure < 65 mmHg, mottling, tachycardia with Heart Rate > 90 bpm, capillary refill time > 3 sec, oliguria (urine output < 0,5 mL/kg/h over 1 hour or more))
- Noradrenaline administration
- Age > 18 years old
- Spontaneous breathing patient requiring oxygen administration without mechanical assistance
Key exclusion criteria (12 listed)
- Intolerance of inspiratory maneuver defined by:
- Hemodynamic response of passive leg raising not evaluable:
- Urgent hemodynamic therapy within half an hour
- Modification of hemodynamic support (fluid therapy or modification of catecholamine dose)
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 |
|---|---|---|
| Echocardiography imagesAddition of a recording loop during routine ultrasound, during which the patient is in simplified standardized ventilation | Device | Spontaneous breathing patient responding to the inclusion criteria |
Primary outcome
Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness
Time frame: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.
the area under the ROC curve of the parameter of simplification of inspiratory effort in relation to the positive hemodynamic response positive haemodynamic response (cardiac preload-dependence) to a passive leg raising manoeuvre
2 secondary outcomes
Performance of inferior vena cava collapsibility index during a deep breath (without monitoring of inspiratory strength) to predict preload responsiveness
Time frame: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.
Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness during different time of cardiac cycle
Time frame: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.
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 10 Apr 2025.
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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?
An observational study of Circulatory Failure, run by University Hospital, Lille 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 5 inclusion and 12 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 10 Apr 2025. 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?
Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness (time frame: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.). 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 10 Apr 2025.