Jugular VeinsNCT03030898
Analysis of Respiratory Variations of the Right Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation
A study testing respiratory variation of the right internal jugular vein in people with Jugular Veins and Ultrasonography, run by Military Hospital of Tunis.
Trial summary
The idea of this work came during a carotid surgery, when we noticed a respiratory variation of the right internal jugular vein. Also, because of the interest of evaluating the preload dependence during an intervention or reanimation where it is difficult to access the other monitoring methods . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jugular Veins, Ultrasonography
- What is being tested?
- respiratory variation of the right internal jugular vein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 28 Dec 2017
- 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
- older than 18 years
- Mechanical Ventilation
Who cannot join
- no exclusion Criteria
About this study
Official title: Analysis of Respiratory Variations of the Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation
The idea of this work came during a carotid surgery, when we noticed a respiratory variation of the right internal jugular vein. Also, because of the interest of evaluating the preload dependence during an intervention or reanimation where it is difficult to access the other monitoring methods . The aim of the study was to test the hypothesis that respiratory changes in right internal jugular vein diameter are similar to respiratory changes in superior and inferior vena cava in mechanically ventilated patients and therefore help to predict fluid responsiveness.
- Conditions
- Jugular Veins, Ultrasonography
- Being tested
- respiratory variation of the right internal jugular vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory variation of the right internal jugular veinDiagnostic test
respiratory variation of the right internal jugular vein vs respiratory variation of superior and inferior cava vena
| Study group | Role | What they receive |
|---|---|---|
| respiratory variation of the right internal jugular vein | Other | Not described Receives: Diagnostic Test: respiratory variation of the right internal jugular vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Variation of the Right Internal Jugular Vein ∆DRIJV
Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .
Measured: through study completion, an average of 1 year
Respiratory Variation of the superior vena cava ∆DSVC
Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Respiratory Variation of the inferior vena cava ∆DIVC
Difference (Δ) between the maximum and the minimum diameter value/minimum diameter .
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion25 Apr 2017 (estimated)
- Study completion28 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jugular VeinsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lebbi Anis, Military Hospital of Tunis
- Investigators
- Anis Lebbi, Study director, Military Hospital of TunisMejdi Ferjaoui, Principal investigator, Military Hospital of TunisTrabelsi Walid, Study chair, Military Hospital of TunisAbdelkader Ben Gabsia, Study chair, Military Hospital of TunisEmel Rafrafi, Study chair, Military Hospital of TunisAmine Skouri, Study chair, Military Hospital of TunisKaouther Fares, Study chair, Military Hospital of TunisWalid Sallami, Study chair, Military Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030898
- Sponsor's protocol ID
- 9829260098237333
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2017
- Last updated
- 25 Jan 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Respiratory Variations of the Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03030898
- Acronym / sponsor ID
- 9829260098237333
- Conditions
- Jugular Veins, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 25 Apr 2017 (estimated)
- Study completion
- 28 Dec 2017 (estimated)
- First posted
- 25 Jan 2017 (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 idea of this work came during a carotid surgery, when we noticed a respiratory variation of the right internal jugular vein. Also, because of the interest of evaluating the preload dependence during an intervention or reanimation where it is difficult to access the other monitoring methods . The aim of the study was to test the hypothesis that respiratory changes in right internal jugular vein diameter are similar to respiratory changes in superior and inferior vena cava in mechanically ventilated patients and therefore help to predict fluid responsiveness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| respiratory variation of the right internal jugular vein | Other | Diagnostic Test: respiratory variation of the right internal jugular vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than 18 years
- Mechanical Ventilation
Key exclusion criteria (1 listed)
- no exclusion Criteria
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 |
|---|---|---|
| respiratory variation of the right internal jugular veinrespiratory variation of the right internal jugular vein vs respiratory variation of superior and inferior cava vena | Diagnostic test | respiratory variation of the right internal jugular vein |
Primary outcome
Respiratory Variation of the Right Internal Jugular Vein ∆DRIJV
Time frame: through study completion, an average of 1 year
Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .
Respiratory Variation of the superior vena cava ∆DSVC
Time frame: through study completion, an average of 1 year
Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .
1 secondary outcome
Respiratory Variation of the inferior vena cava ∆DIVC
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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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.
Anis Lebbi study director
Military Hospital of Tunis
Mejdi Ferjaoui principal investigator
Military Hospital of Tunis
Trabelsi Walid study chair
Military Hospital of Tunis
Questions about this trial
What is this clinical trial studying?
A study testing respiratory variation of the right internal jugular vein in people with Jugular Veins and Ultrasonography, run by Military Hospital of Tunis.
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 1 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Respiratory Variation of the Right Internal Jugular Vein ∆DRIJV (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 25 Jan 2017.