- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030898
Analysis of Respiratory Variations of the Right Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation
January 21, 2017 updated by: Lebbi Anis, Military Hospital of Tunis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- older than 18 years
- Mechanical Ventilation
Exclusion Criteria:
- no exclusion Criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: respiratory variation of the right internal jugular vein
|
respiratory variation of the right internal jugular vein vs respiratory variation of superior and inferior cava vena
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 .
|
through study completion, an average of 1 year
|
|
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 .
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Variation of the inferior vena cava ∆DIVC
Time Frame: through study completion, an average of 1 year
|
Difference (Δ) between the maximum and the minimum diameter value/minimum diameter .
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anis Lebbi, Military Hospital of Tunis
- Principal Investigator: Mejdi Ferjaoui, Military Hospital of Tunis
- Study Chair: Trabelsi Walid, Military Hospital of Tunis
- Study Chair: Abdelkader Ben Gabsia, Military Hospital of Tunis
- Study Chair: Emel Rafrafi, Military Hospital of Tunis
- Study Chair: Amine Skouri, Military Hospital of Tunis
- Study Chair: Kaouther Fares, Military Hospital of Tunis
- Study Chair: Walid Sallami, Military Hospital of Tunis
- Study Chair: Iheb Labbene, Military Hospital of Tunis
- Study Chair: Mustapha Ferjani, Military Hospital of Tunis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ANTICIPATED)
April 25, 2017
Study Completion (ANTICIPATED)
December 28, 2017
Study Registration Dates
First Submitted
January 19, 2017
First Submitted That Met QC Criteria
January 21, 2017
First Posted (ESTIMATE)
January 25, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
January 25, 2017
Last Update Submitted That Met QC Criteria
January 21, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 9829260098237333
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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