Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563427
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Reliability of Internal Jugular Ultrasound an Observational Transversal Study AIJV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Study on the Reliability of Four Ultrasound Measures the Antero-posterior Diameter the End-exipratory Area the Aspect Ratio and the Collapsibility Index of Internal Jugular Vein Evaluated on Patients Admitted to Five Medicine Departments
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIJV
Brief Summary:
This is an observational transversal study without intervention on the inter-rater reliability of four ultrasound measures of Internal Jugular Veins
Aims are 1 to test the inter-rater reliability among a group of ultrasound measurements of internal jugular vein using a group of images registered in several acoustic views of neck of patients admitted in Internal Medicine Dept of five Italian Hospitals 2to measure the differences between ultrasound measurements in different acoustic views
The reliability will be tested by recording Ultrasound measures on images registered using an Utrasound protocol on 100 patients
Aims are 1 to test the inter-rater reliability among a group of ultrasound measurements of internal jugular vein using a group of images registered in several acoustic views of neck of patients admitted in Internal Medicine Dept of five Italian Hospitals 2to measure the differences between ultrasound measurements in different acoustic views
The reliability will be tested by recording Ultrasound measures on images registered using an Utrasound protocol on 100 patients
Detailed Description:
Introduction Many studies suggest that the ultrasound of Internal Jugular Vein IJV is a method valid in predicting volume status and Central Venous Pressure CVP among critical patients 1-2
Because this method is very easy fast and applicable in several setting if research will confirm its accuracy in detecting congestion and prognosis it could have an important role in clinical practice
The Internal jugular vein changes its size during the respiratory cicle it enlarges in expiration and reduces in inspiration
Usually the expiratory maximum diameters and area have been used by researchers to test the IJV ultrasound accuracy in predicting Central Venous Pressure and volume status 12
Many ultrasound measures of IJV have been tested 3-8 the antero-posterior end-expiratory Internal Jugular Vein diameter AP-IJV max the end-exipratory IJV area maximal area in transversal section CSA-IJV max the ratio between the AP-IJV max and transversal IJV diameter LL-IJV max the Aspect ratio AP-IJV maxLL-IJV max the Collapsibility index of IJV the respiratory variation percentage calculated as maximum diameter minus minimum diametermaximum diameter
According to the literature a low value of the collapsibility index suggests high Central Venous Pressure CVP Large diameters and areas of the internal jugular vein are recorded in patients with high CVP
Unfortunately many factors could affect IJV measurements using Ultrasound patient position the side of exam right vs left previous neck surgery IJV thrombosis presence of catheters
Furthermore there is not a standardization of ultrasound technique because the researchers used several protocols to validate the method
For these reasons our hypothesis is that the IJV ultrasound might have a great inter-rater variability and that it is not reliable
Therefore our aim is to test the inter-rater reliability among a group of ultrasound measurements of internal jugular vein using a group of images registered in several acoustic views of neck of patients admitted in Internal Medicine Dept of five Italian Hospitals
Secondary objective is to measure the differences between ultrasound measurements in different acoustic views
Methods Design setting and data collection Its a cross-sectional transversal observational study that will be conducted in five Italian Hospitals from September 1 2024 to September 30 2024 We will follow the Strobe checklist and guidelines to plan and conduct the study 9
The study has been approved by the Ethical Committee Area Vasta Emilia Centro AVEC code 725-2023-OSS-AUSLBO
For each patient the following variables will be collected age sex weight height Body mass index Body surface area cause of hospitalization and ultrasound measurements of the jugular below described
Ultrasound imaging and protocol During the ultrasound examination that will be performed using an Esaote Mylab system the patients will be with the trunk at 45 The examination will be performed in the lateral region of the right neck using the following acoustic windows supraclavicular two cm above the clavicle cricoid and at the apex of the sternocleidomastoid muscle mandibular angle
A vascular probe 10 Mhz linear array will be used in B Mode and M Mode Six images per patient will be recorded by the twenty patients recruited for a total of 120 images
The sonographers after a short theoretical and practical course one hour of theory and one hour of practice will measure on the images previously recorded independently and without communicating with each other the four ultrasound measurements to be tested illustrated in the Figure 1-4 of the Appendix the Antero-posterior expiratory max diameter AP-IJV max maximum area CSA-IJV max the Aspect ratio AP-IJV max Ll-IJV the collapsibility index IJV-c
To avoid bias of selection of participants all patients admitted to each cause in the Study Center will be recruited The ultrasound researchers will not know the purpose of the study the causes of hospitalization of the patient nor the values of measurements made by the other researchers-echographers The researcher who will collect the clinical-anagraphic data and the ultrasound variables will be not the same researcher who will performe the ultrasound protocol
To avoid the biases of procedure and measurement of ultrasound variables sonograpfers who will perform the protocol will be instructed before the study with the same course conducted by the same teacher
Each researcher will not know the measurements recorded by the other researchers in the same session
To calculate the sample estimate we predict an expected value of ICC09 a minimum acceptable value of ICC06 according to the literature 3 10 a statistical significance level of 005 alpha error a rater number of 12 11 students and the gold standard a 10 share of lost data
In this way using the calculation method described in the link httpswnarifingithubiosscssicchtml we estimate that a sample of 10 groups of images would be needed for global reliability
The medians and relative Interquartile IQR ranges of the ultrasound measurements will be compared in the different acoustic windows
Reliability values measured with the ICC inter-class correlation coefficient among the sonographers of the 5 hospitals will be also compared
Statistical analysis The median and range Interquartile IQR and Box plot will be used to describe and present the collected data We consider statistically significant a value of p less than 005
To evaluate inter-operator reliability ICC inter-class correlation coefficient statistics will be used a measure that has a range of values between zero expression of maximum variability and the one high reliability and minimum variability
We use the reliability level classification proposed by Koo TK et al 11 we consider poor realiability an ICC value less than 05 moderate an ICC value 05-075 good an ICC 075-09 an excellent ICC09
References
1 Wang MK Piticaru J Kappe C Mikhaeil M Mbuagbaw L Internal jugular vein ultrasound for the diagnosis of hypovolemia and hypervolemia in acutely ill adults a systematic review and meta analysis Internal and Emergency Medicine 2022 171521-1532
2 Parenti N et al Role of Internal Jugular Vein Ultrasound Measurements in the Assessment of Central Venous Pressure in Spontaneously Breathing Patients A Systematic Review Journal of Acute Medicine 92 39-48 2019
3 Simon MA Kliner DE Girod JP Moguillansky D Villanueva F et al Detection of elevated right atrial pressure using a simple bedside ultrasound measure Am Heart J 2010159421-7
4 Simon MA Schnatz RG Jared D Romeo JD Pacella JJ Bedside Ultrasound Assessment of Jugular Venous Compliance as a Potential Point-of-Care Method to Predict Acute Decompensated Heart Failure 30-Day Readmission J Am Heart Assoc 2018 Aug 7715
5 Tzadok B Shapira S Tal-Or E Ultrasound of Jugular Veins for Assessment of Acute Dyspnea in Emergency Departments and for the Assessment of Acute Heart Failure Isr Med Assoc J 2018 May205308-310
6 Vaidya GN Ghafghazi S Correlation of internal jugular and subclavian vein diameter variation on bedside ultrasound with invasive right heart catheterization Indian Heart J Mar-Apr 2021732231-235
7 Ammirati E Marchetti D Colombo G Pellicori P Gentile P DAngelo L et al Estimation of Right Atrial Pressure by Ultrasound-Assessed Jugular Vein Distensibility in Patients With Heart Failure Circ Heart Fail 2024 Feb172e010973 doi 101161CIRCHEARTFAILURE123010973 Epub 2024 Feb 1
8 Albaeni A Sharma M Ahmad M Khalife WI Accurate Estimation of Right-Filling Pressure Using Handheld Ultrasound Score in Patients with Heart Failure Am J Med 2022 May1355634-640 doi 101016jamjmed202111020 Epub 2021 Dec 31
9 Von Elm E Altman DG Egger M Pocock SJ Gøtzsche PC Vandenbroucke JP STROBE Initiative The Strengthening the Reporting of Observational Studies in Epidemiology STROBEstatement guidelines for reporting observational studies J Clin Epidemiol 2008 Apr614344-9 PMID 18313558
10 Donahue SP Wood JP Patel BM Quinn JV Correlation of sonographic measurements of the internal jugular vein with central venous pressure Am J Emerg Med 200927851-855 doi101016jajem200806005
11 Koo TK Li MY A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research J Chiropr Med 2016 Jun152155-63 doi 101016jjcm201602012
Because this method is very easy fast and applicable in several setting if research will confirm its accuracy in detecting congestion and prognosis it could have an important role in clinical practice
The Internal jugular vein changes its size during the respiratory cicle it enlarges in expiration and reduces in inspiration
Usually the expiratory maximum diameters and area have been used by researchers to test the IJV ultrasound accuracy in predicting Central Venous Pressure and volume status 12
Many ultrasound measures of IJV have been tested 3-8 the antero-posterior end-expiratory Internal Jugular Vein diameter AP-IJV max the end-exipratory IJV area maximal area in transversal section CSA-IJV max the ratio between the AP-IJV max and transversal IJV diameter LL-IJV max the Aspect ratio AP-IJV maxLL-IJV max the Collapsibility index of IJV the respiratory variation percentage calculated as maximum diameter minus minimum diametermaximum diameter
According to the literature a low value of the collapsibility index suggests high Central Venous Pressure CVP Large diameters and areas of the internal jugular vein are recorded in patients with high CVP
Unfortunately many factors could affect IJV measurements using Ultrasound patient position the side of exam right vs left previous neck surgery IJV thrombosis presence of catheters
Furthermore there is not a standardization of ultrasound technique because the researchers used several protocols to validate the method
For these reasons our hypothesis is that the IJV ultrasound might have a great inter-rater variability and that it is not reliable
Therefore our aim is to test the inter-rater reliability among a group of ultrasound measurements of internal jugular vein using a group of images registered in several acoustic views of neck of patients admitted in Internal Medicine Dept of five Italian Hospitals
Secondary objective is to measure the differences between ultrasound measurements in different acoustic views
Methods Design setting and data collection Its a cross-sectional transversal observational study that will be conducted in five Italian Hospitals from September 1 2024 to September 30 2024 We will follow the Strobe checklist and guidelines to plan and conduct the study 9
The study has been approved by the Ethical Committee Area Vasta Emilia Centro AVEC code 725-2023-OSS-AUSLBO
For each patient the following variables will be collected age sex weight height Body mass index Body surface area cause of hospitalization and ultrasound measurements of the jugular below described
Ultrasound imaging and protocol During the ultrasound examination that will be performed using an Esaote Mylab system the patients will be with the trunk at 45 The examination will be performed in the lateral region of the right neck using the following acoustic windows supraclavicular two cm above the clavicle cricoid and at the apex of the sternocleidomastoid muscle mandibular angle
A vascular probe 10 Mhz linear array will be used in B Mode and M Mode Six images per patient will be recorded by the twenty patients recruited for a total of 120 images
The sonographers after a short theoretical and practical course one hour of theory and one hour of practice will measure on the images previously recorded independently and without communicating with each other the four ultrasound measurements to be tested illustrated in the Figure 1-4 of the Appendix the Antero-posterior expiratory max diameter AP-IJV max maximum area CSA-IJV max the Aspect ratio AP-IJV max Ll-IJV the collapsibility index IJV-c
To avoid bias of selection of participants all patients admitted to each cause in the Study Center will be recruited The ultrasound researchers will not know the purpose of the study the causes of hospitalization of the patient nor the values of measurements made by the other researchers-echographers The researcher who will collect the clinical-anagraphic data and the ultrasound variables will be not the same researcher who will performe the ultrasound protocol
To avoid the biases of procedure and measurement of ultrasound variables sonograpfers who will perform the protocol will be instructed before the study with the same course conducted by the same teacher
Each researcher will not know the measurements recorded by the other researchers in the same session
To calculate the sample estimate we predict an expected value of ICC09 a minimum acceptable value of ICC06 according to the literature 3 10 a statistical significance level of 005 alpha error a rater number of 12 11 students and the gold standard a 10 share of lost data
In this way using the calculation method described in the link httpswnarifingithubiosscssicchtml we estimate that a sample of 10 groups of images would be needed for global reliability
The medians and relative Interquartile IQR ranges of the ultrasound measurements will be compared in the different acoustic windows
Reliability values measured with the ICC inter-class correlation coefficient among the sonographers of the 5 hospitals will be also compared
Statistical analysis The median and range Interquartile IQR and Box plot will be used to describe and present the collected data We consider statistically significant a value of p less than 005
To evaluate inter-operator reliability ICC inter-class correlation coefficient statistics will be used a measure that has a range of values between zero expression of maximum variability and the one high reliability and minimum variability
We use the reliability level classification proposed by Koo TK et al 11 we consider poor realiability an ICC value less than 05 moderate an ICC value 05-075 good an ICC 075-09 an excellent ICC09
References
1 Wang MK Piticaru J Kappe C Mikhaeil M Mbuagbaw L Internal jugular vein ultrasound for the diagnosis of hypovolemia and hypervolemia in acutely ill adults a systematic review and meta analysis Internal and Emergency Medicine 2022 171521-1532
2 Parenti N et al Role of Internal Jugular Vein Ultrasound Measurements in the Assessment of Central Venous Pressure in Spontaneously Breathing Patients A Systematic Review Journal of Acute Medicine 92 39-48 2019
3 Simon MA Kliner DE Girod JP Moguillansky D Villanueva F et al Detection of elevated right atrial pressure using a simple bedside ultrasound measure Am Heart J 2010159421-7
4 Simon MA Schnatz RG Jared D Romeo JD Pacella JJ Bedside Ultrasound Assessment of Jugular Venous Compliance as a Potential Point-of-Care Method to Predict Acute Decompensated Heart Failure 30-Day Readmission J Am Heart Assoc 2018 Aug 7715
5 Tzadok B Shapira S Tal-Or E Ultrasound of Jugular Veins for Assessment of Acute Dyspnea in Emergency Departments and for the Assessment of Acute Heart Failure Isr Med Assoc J 2018 May205308-310
6 Vaidya GN Ghafghazi S Correlation of internal jugular and subclavian vein diameter variation on bedside ultrasound with invasive right heart catheterization Indian Heart J Mar-Apr 2021732231-235
7 Ammirati E Marchetti D Colombo G Pellicori P Gentile P DAngelo L et al Estimation of Right Atrial Pressure by Ultrasound-Assessed Jugular Vein Distensibility in Patients With Heart Failure Circ Heart Fail 2024 Feb172e010973 doi 101161CIRCHEARTFAILURE123010973 Epub 2024 Feb 1
8 Albaeni A Sharma M Ahmad M Khalife WI Accurate Estimation of Right-Filling Pressure Using Handheld Ultrasound Score in Patients with Heart Failure Am J Med 2022 May1355634-640 doi 101016jamjmed202111020 Epub 2021 Dec 31
9 Von Elm E Altman DG Egger M Pocock SJ Gøtzsche PC Vandenbroucke JP STROBE Initiative The Strengthening the Reporting of Observational Studies in Epidemiology STROBEstatement guidelines for reporting observational studies J Clin Epidemiol 2008 Apr614344-9 PMID 18313558
10 Donahue SP Wood JP Patel BM Quinn JV Correlation of sonographic measurements of the internal jugular vein with central venous pressure Am J Emerg Med 200927851-855 doi101016jajem200806005
11 Koo TK Li MY A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research J Chiropr Med 2016 Jun152155-63 doi 101016jjcm201602012
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None