Collapsibility of the Inferior Vena CavaNCT01644760
Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation
A study of Collapsibility of the Inferior Vena Cava, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility of the inferior vena cava. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Collapsibility of the Inferior Vena Cava
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to 17 Sep 2012
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The volunteer must have given his/her informed and signed consent
- The volunteer must be insured or beneficiary of a health insurance plan
Who cannot join
- The volunteer is participating in another study
- The volunteer is in an exclusion period determined by a previous study
- The volunteer is under judicial protection, under tutorship or curatorship
- The volunteer refuses to sign the consent
- It is impossible to correctly inform the volunteer
- The patient is pregnant, parturient, or breastfeeding
Show all 11Show fewer
- The volunteer has known heart disease like heart failure, cardiac arrhythmia
- The volunteer takes cardiotropics
- The volunteer has known lung disease: obstructive or restrictive respiratory failure
- The volunteer has clinical signs of COPD (coughing with morning sputum in a smoking subject)
- Any emergency situation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation: A Physiological Study on Healthy Volunteers
The main objective of this study is to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility of the inferior vena cava.
Read the detailed description
Secondary objectives of this study are:
- to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 40% collapsibility of the inferior vena cava (IVC).
- to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 100% collapsibility of the IVC.
- to determine the location of the cutting plane for the TM analysis of collapsibility of the IVC.
- to evaluate the hemodynamic conditions of normal healthy volunteers.
- to detect any abnormality of cardiac function.
- Conditions
- Collapsibility of the Inferior Vena Cava
- Being tested
- Ultrasounds with controlled breathing
- Keywords
- Diaphragmatic excursion, normality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasounds with controlled breathingProcedure or surgery
The patient will have cardiac, abdominal and thoracic ultrasounds with controlled and monitored inspiratory effort. This gesture takes about 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Experimental | Healthy subjects with spontaneous ventilation, 18 to 50 years of age. Receives: Procedure: Ultrasounds with controlled breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collapsibility score for the IVC diameter
percentage = ((max-min)/average)*100%
Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion.
Measured: Baseline (Day 0; cross-sectional study)
Collapsibility score for the IVC diameter >= 50% (presence/absence)
percentage = ((max-min)/average)*100%
Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion.
Measured: Baseline (Day 0; cross-sectional study)
Diaphragmatic excursion
Maximum distance between the position of the diaphragmatic dome during inspiration versus expiration (cm)
Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion.
Measured: Baseline (Day 0; cross-sectional study)
Secondary outcomes (6)
Collapsibility score for the IVC diameter >= 40% (presence/absence)
percentage = ((max-min)/average)*100%
Measured: Baseline (Day 0; cross sectional study)
Collapsibility score for the IVC diameter >= 60% (presence/absence)
percentage = ((max-min)/average)*100%
Measured: Baseline (Day 0; cross sectional study)
Mitral Doppler Wave E speed
cm/s
Measured: Baseline (Day 0; cross sectional study)
Mitral Doppler Wave A speed
cm/s
Measured: Baseline (Day 0; cross sectional study)
Tissue Doppler Wave E' speed
cm/s
Measured: Baseline (Day 0; cross sectional study)
Simpson: FEVG
%
Measured: Baseline (Day 0; cross sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startSep 2012
- Primary completion17 Sep 2012
- Study completion17 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Collapsibility of the Inferior Vena CavaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Muller, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644760
- Sponsor's protocol ID
- LOCAL/2012/LM-01
- Other IDs
- 2012-A00625-38
- Status last verified
- Mar 2015
- First submitted
- 17 Jul 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Gignon L, Roger C, Bastide S, Alonso S, Zieleskiewicz L, Quintard H, Zoric L, Bobbia X, Raux M, Leone M, Lefrant JY, Muller L. Influence of Diaphragmatic Motion on Inferior Vena Cava Diameter Respiratory Variations in Healthy Volunteers. Anesthesiology. 2016 Jun;124(6):1338-46. doi: 10.1097/ALN.0000000000001096.
PubMed 27003619
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation: A Physiological Study on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01644760
- Acronym / sponsor ID
- LOCAL/2012/LM-01
- Conditions
- Collapsibility of the Inferior Vena Cava
- Keywords
- Diaphragmatic excursion, normality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 17 Sep 2012 (actual)
- Study completion
- 17 Sep 2012 (actual)
- First posted
- 19 Jul 2012 (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.
The main objective of this study is to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility of the inferior vena cava.
Detailed description
Secondary objectives of this study are:
- to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 40% collapsibility of the inferior vena cava (IVC).
- to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 100% collapsibility of the IVC.
- to determine the location of the cutting plane for the TM analysis of collapsibility of the IVC.
- to evaluate the hemodynamic conditions of normal healthy volunteers.
- to detect any abnormality of cardiac function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Procedure: Ultrasounds with controlled breathingHealthy subjects with spontaneous ventilation, 18 to 50 years of age. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The volunteer must have given his/her informed and signed consent
- The volunteer must be insured or beneficiary of a health insurance plan
Key exclusion criteria (11 listed)
- The volunteer is participating in another study
- The volunteer is in an exclusion period determined by a previous study
- The volunteer is under judicial protection, under tutorship or curatorship
- The volunteer refuses to sign the consent
- It is impossible to correctly inform the volunteer
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 |
|---|---|---|
| Ultrasounds with controlled breathingThe patient will have cardiac, abdominal and thoracic ultrasounds with controlled and monitored inspiratory effort. This gesture takes about 40 minutes. | Procedure or surgery | Study population |
Primary outcome
Collapsibility score for the IVC diameter
Time frame: Baseline (Day 0; cross-sectional study)
percentage = ((max-min)/average)*100% Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion.
Collapsibility score for the IVC diameter >= 50% (presence/absence)
Time frame: Baseline (Day 0; cross-sectional study)
percentage = ((max-min)/average)*100% Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion.
Diaphragmatic excursion
Time frame: Baseline (Day 0; cross-sectional study)
Maximum distance between the position of the diaphragmatic dome during inspiration versus expiration (cm) Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion.
6 secondary outcomes
Collapsibility score for the IVC diameter >= 40% (presence/absence)
Time frame: Baseline (Day 0; cross sectional study)
Collapsibility score for the IVC diameter >= 60% (presence/absence)
Time frame: Baseline (Day 0; cross sectional study)
Mitral Doppler Wave E speed
Time frame: Baseline (Day 0; cross sectional study)
Mitral Doppler Wave A speed
Time frame: Baseline (Day 0; cross sectional study)
Tissue Doppler Wave E' speed
Time frame: Baseline (Day 0; cross sectional study)
Simpson: FEVG
Time frame: Baseline (Day 0; cross sectional study)
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 19 Nov 2025.
- Results publication: PubMed 27003619Gignon L, Roger C, Bastide S, Alonso S, Zieleskiewicz L, Quintard H, Zoric L, Bobbia X, Raux M, Leone M, Lefrant JY, Muller L. Influence of Diaphragmatic Motion on Inferior Vena Cava Diameter Respiratory Variations in Healthy Volunteers. Anesthesiology. 2016 Jun;124(6):1338-46. doi: 10.1097/ALN.0000000000001096.
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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.
Laurent Muller, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Collapsibility of the Inferior Vena Cava, run by Centre Hospitalier Universitaire de Nīmes 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 2 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 19 Nov 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?
Collapsibility score for the IVC diameter (time frame: Baseline (Day 0; cross-sectional study)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644760, which also lists 1 linked publication.
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 19 Nov 2025.