Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns As Predictors of Fluid Responsiveness

Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns As Predictors of Response to Fluid Administration in Elective Surgery Patients

The measurement of internal jugular vein distensibility index corresponds to the measurement of stroke volume using trans-thoracic Doppler echocardiography in assessing the response to fluid administration in elective surgical patients.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Monitoring; Fluid Responsiveness
• Intervention / Treatment: Device: Ultrasonography of Internal Jugular Vein; Device: Doppler Echocardiograhy

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Rumah Sakit Cipto Mangunkusumo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18-65 years undergoing elective surgery with general anesthesia at RSUPN dr. Cipto Mangunkusumo Jakarta.

Description

Inclusion Criteria:

1. Utilizing intraoperative mechanical ventilation with a tidal volume of 8 ml/kg (PBW).
2. ASA physical status 1-3.
3. Mongoloid ethnicity.
4. Willing to participate in the research and sign the informed consent.

Exclusion Criteria:

1. Patients with symptoms and signs of fluid overload, such as pulmonary edema, pleural effusion, ascites, and peripheral edema.
2. Patients with chronic or acute kidney dysfunction, renal replacement therapy history, and/or oliguria (urine output <0.5 ml/kg/hour).
3. Patients with cardiovascular diseases, including heart failure, cardiac arrhythmias, moderate-to-severe valvular abnormalities, a history of angina/myocardial infarction, pulmonary hypertension, and peripheral artery disease.
4. Patients with anatomical abnormalities in the neck and chest region that make it impractical to perform jugular vein ultrasound and transthoracic echocardiography.
5. Jugular vein thrombosis.
6. Superior vena cava syndrome.
7. Placement of jugular vein catheter.
8. Body mass index (BMI) greater than 30.0 kg/m2.
9. Patients with contraindications to the use of muscle relaxants.
10. Patients with lung hyperinflation and pleural effusion.

Drop out criteria:

1. Patients who wish to withdraw from the study.
2. Post-anesthesia induction complications and emergencies.
3. Transthoracic echocardiography provides a less representative image due to difficult acoustic window.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IJV distensibility index correlation to fluid responsiveness	Correlation between IJV distensibility index and fluid responsiveness defined as increase of stroke volume more than 10% after fluid challenge	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of IJV distensibility index in fluid responders and non-fluid responders.		1 day
Detection of sensitivity, specificity, positive predictive value, negative predictive value, and best cut off value of IJV distensibility index to predict fluid responsiveness	By ROC curve and Youden index	1 day
Correlation of IJV distensibility index and stroke volume		1 day
Innominate vein flow velocity correlation to fluid responsiveness	Correlation between Innominate vein flow velocity and fluid responsiveness defined as increase of stroke volume more than 10% after fluid challenge	1 day

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Dita Aditianingsih, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Internal Jugular Venous Distensibility Index; Innominate Venous Flow Patterns
• Other Study ID Numbers: IndonesiaUAnes044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No