Bedside Ultrasound for Fluid Estimation

Catheterization Clinical Trial

Official title:

Correlation of Internal Jugular and Inferior Vena Cava Diameter Variation on Bedside Ultrasound With Invasive Right Heart Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05159063
• Other study ID #: 67340
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to standardize patient positioning during bedside ultrasound assessment of internal jugular vein (IJV) and correlate the results with invasive hemodynamics obtained immediately after. The study hypothesizes that the respiratory variation in the size of IJV, as estimated through ultrasound at bedside, is an accurate estimation of the patient's actual right atrial pressure estimated through right heart catheterization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: April 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Undergoing right heart catheterization

Exclusion Criteria:

• Superior vena cava obstruction or compression
• Severe tricuspid regurgitation
• Mechanically ventilated patients

Related Conditions & MeSH terms

• Catheterization

Intervention

Device:
• Ultrasound imaging
Patients scheduled to undergo right heart catheterization (RHC) as their standard of care will be included in the study. The patient will be positioned supine at 0 degrees with normal restful breathing and patient looking straight up. After the right sternocleidomastoid muscle is identified, internal jugular vein (IJV) will be imaged at the apex of the triangle formed by the sternal and clavicular heads of the muscle. Similarly, the inferior vena cava (IVC) will be imaged at the caudal end of the sternum. The diameters of both the veins will be noted during normal respiration. The patients will then be asked to sniff and collapsibility of the veins will be noted. No pressure will be applied on the neck. The anticipated duration for image acquisition is between 5 to 10 minutes. The patients will undergo the scheduled RHC within 1 hour as scheduled.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Gaurang Vaidya

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vaidya GN, Kolodziej A, Stoner B, Galaviz JV, Cao X, Heier K, Thompson M, Birks E, Campbell K. Bedside ultrasound of the internal jugular vein to assess fluid status and right ventricular function: The POCUS-JVD study. Am J Emerg Med. 2023 Jun 6;70:151-156. doi: 10.1016/j.ajem.2023.05.042. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross-sectional diameters of the internal jugular vein (IJV)	The respiratory variation percentage will assessed using M-mode of the ultrasound while the patient is breathing normally. The maximum and minimum anteroposterior diameter will be noted using M-mode (in mm).	5 minutes
Primary	Cross-sectional diameters of the internal jugular vein (IJV)	Diameter variation index will be calculated as: (maximum diameter - minimum diameter)/ body surface area.	5 minutes
Primary	Sniff collapsibility of IJV	Complete collapse (0cm) of the anteroposterior diameter of IJV on sniff maneuver by the patient, as assessed by M-mode on the ultrasound.	10 minutes
Primary	Cross-sectional diameters of the inferior vena cava (IVC)	Maximum diameter - noted using M-mode (in mm) of the ultrasound machine.	5 minutes
Primary	Cross-sectional diameters of the inferior vena cava (IVC)	Respiratory variation - assessed using M-mode of the ultrasound while the patient is breathing normally. This will be calculated as (maximum diameter - minimum diameter)/maximum diameter and expressed as a percentage. The maximum and minimum diameters will be noted using M-mode (in mm).	5 minutes
Primary	Cross-sectional diameters of the inferior vena cava (IVC)	Sniff collapsibility - Complete collapse (0cm) of the cross sectional diameter of IVC on sniff maneuver by the patient, as assessed by M-mode of the ultrasound.	5 minutes