Clinical trial NCT04173741: Is There Any Correlation Between Respiratory Variation Ratios of Internal Jugular Vein and Inferior Vena Cava?
Official title: A Correlation Study in the Intensive Care Unit Between the Respiratory Variation Ratios of Internal Jugular Vein and Inferior Vena Cava Before and After Passive Leg Raise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: Positive Pressure Ventilation
Fluid Responsiveness
Passive Leg Raise
Inferior Vena Cava
Internal Jugular Vein
Interobserver Variability
Ultrasound
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients in the intensive care unit over 18 years of age

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated
* Over 18 years of age

Exclusion Criteria:

* Infection in the site of measurement areas
* Surgical sutures in the site of measurement areas
* Intraabdominal hypertension
* Severe aortic regurgitation
* Lower extremity amputation

Primary outcomes:
measure: Ultrasonography (USG) Measurements
timeFrame: through study completion, 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Hospital Anesthesiology Intensive Care Unit
Study officials:
affiliation: Hacettepe University
name: Asli Melek
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.