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Intravascular volume assesment is important for the management of the patients in the intensive care unit. Respiratory variation ratio of the inferior vena cava (IVC) can be determined by ultrasonography (USG) and is a useful tool for hemodynamic evaluation of the patient.
Aim of this study is to search for correlation between respiratory variation ratios of the internal jugular vein (IJV) and the IVC before and after passive leg raise. Another aim of this study is to search for variability between ultrasonographic measurements of different doctors.
The investigators measure the internal jugular vein (IJV) diameter in the short axis by using the linear probe (12-5 MHz) and M-mode of the ultrasound device in the junction of cricothyroid membrane level and midclavicular line. The inferior vena cava (IVC) is visualized in the subxiphoid long axis by using the convex probe (5-1 MHz). Diameter of the IVC is measured 2 cm caudally to the junction of the hepatic vein in M-mode. All measurements are done separately by 3 different doctors; one senior anesthesiology resident, one anesthesiology and critical care medicine fellow and one professor in anesthesiology and critical care. The first measurements of the IVC and the IJV are done in the supine position and the second ones are done after passive leg raise. Passive leg raise is done for 1 minute in the first group and for 3 minutes in the second group. Then distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices are calculated. No fluid therapy or medication are given to the patients according to these measurements.
Oxygen saturation, hearth rate and blood pressure levels are recorded before and after the measurements. The investigators also record age, gender, weight, height, body mass index, causes of admission, comorbidities, ventilator settings, vasoactive and diuretic medications, fluid intake and output volumes, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sepsis-Related Organ Failure Assessment (SOFA) scores in the day of admission, Acute Physiology Score (APS) and SOFA scores in the day of measurement and length of stay in the intensive care unit.
Patients with infection or surgical sutures in the site of measurement areas, intraabdominal hypertension, severe aortic regurgitation or lower extremity amputation history are excluded from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leg Rise Position - 3 Minutes | Patients who stayed in passive leg rise position for 3 minutes |
| |
| Leg Rise Position - 1 Minute | Patients who stayed in passive leg rise position for 1 minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USG measurement | Other | IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonography (USG) Measurements | Because of the medium-high interrater correlation between USG measurements of the physicians, statistical analysis were done with the mean of USG measurements of 3 doctors. | through study completion, 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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Mechanically ventilated patients in the intensive care unit over 18 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Asli Melek | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Hospital Anesthesiology Intensive Care Unit | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27277237 | Background | Nakamura K, Tomida M, Ando T, Sen K, Inokuchi R, Kobayashi E, Nakajima S, Sakuma I, Yahagi N. Cardiac variation of inferior vena cava: new concept in the evaluation of intravascular blood volume. J Med Ultrason (2001). 2013 Jul;40(3):205-9. doi: 10.1007/s10396-013-0435-6. Epub 2013 Feb 27. | |
| 27108039 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Leg Rise Position - 3 Minutes | Patients who stayed in passive leg rise position for 3 minutes Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done. |
| FG001 | Leg Rise Position - 1 Minute | Patients who stayed in passive leg rise position for 1 minute Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
IVC cannot be visualized by any of the physicians in 1 patient in Group A and in 1 patient in Group B. Statistical analysis is done with total of 44 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Patients who stayed in passive leg rise position for 3 minutes USG measurement: IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ultrasonography (USG) Measurements | Because of the medium-high interrater correlation between USG measurements of the physicians, statistical analysis were done with the mean of USG measurements of 3 doctors. | Posted | Median | Full Range | centimeter | through study completion, 3 days |
|
Through study completion, an average of 1 month.
Only All-Cause Mortality were assessed. Serious and Other (Not Including Serious) Adverse Events were not assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leg Rise Position - 3 Minutes | Patients who stayed in passive leg rise position for 3 minutes Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Asli Melek | Hacettepe University | +905376636789 | aslimelek121@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2019 | Aug 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Nakamura K, Qian K, Ando T, Inokuchi R, Doi K, Kobayashi E, Sakuma I, Nakajima S, Yahagi N. Cardiac Variation of Internal Jugular Vein for the Evaluation of Hemodynamics. Ultrasound Med Biol. 2016 Aug;42(8):1764-70. doi: 10.1016/j.ultrasmedbio.2016.03.003. Epub 2016 Apr 20. |
| 22386226 | Background | Akilli NB, Cander B, Dundar ZD, Koylu R. A new parameter for the diagnosis of hemorrhagic shock: jugular index. J Crit Care. 2012 Oct;27(5):530.e13-8. doi: 10.1016/j.jcrc.2012.01.011. Epub 2012 Mar 3. |
| 20016380 | Background | Preau S, Saulnier F, Dewavrin F, Durocher A, Chagnon JL. Passive leg raising is predictive of fluid responsiveness in spontaneously breathing patients with severe sepsis or acute pancreatitis. Crit Care Med. 2010 Mar;38(3):819-25. doi: 10.1097/CCM.0b013e3181c8fe7a. |
| BG001 | Group B | Patients who stayed in passive leg rise position for 1 minute USG measurement: IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Leg Rise Position - 1 Minute | Patients who stayed in passive leg rise position for 1 minute Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. Internal jugular vein (IJV) visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done. |
|
|
| 9 |
| 23 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Leg Rise Position - 1 Minute | Patients who stayed in passive leg rise position for 1 minute Ultrasonography (USG) measurement: Inferior vena cava (IVC) was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. Internal jugular vein (IJV) diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done. | 12 | 23 | 0 | 0 | 0 | 0 |
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