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

Completed

• Conditions: Fluid Responsiveness; Hemodynamic Monitoring

• Registration Number: NCT05930600
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-05
• Primary Completion: 2023-07-31
• Study Completion: 2023-09-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Innominate vein flow velocity correlation to fluid responsiveness	1 day	Correlation between Innominate vein flow velocity and fluid responsiveness defined as increase of stroke volume more than 10% after fluid challenge
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	1 day	By ROC curve and Youden index
Correlation of IJV distensibility index and stroke volume	1 day

Trial Locations

Locations (1)

Rumah Sakit Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia