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

NCT05930600 | Completed

• 1 other identifier: IndonesiaUAnes044
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Responsiveness; Hemodynamic Monitoring

Keywords

Internal Jugular Venous Distensibility Index; Innominate Venous Flow Patterns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Correlation of IJV distensibility index and stroke volume

  1 day

• Innominate vein flow velocity correlation to fluid responsiveness

  1 day

Interventions

Ultrasonography of Internal Jugular Vein DEVICE

Non invasive monitoring of fluid responsiveness

Doppler Echocardiograhy DEVICE

Non invasive monitoring of fluid responsiveness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients with symptoms and signs of fluid overload, such as pulmonary edema, pleural effusion, ascites, and peripheral edema.
• Patients with chronic or acute kidney dysfunction, renal replacement therapy history, and/or oliguria (urine output \<0.5 ml/kg/hour).
• 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.
• Patients with anatomical abnormalities in the neck and chest region that make it impractical to perform jugular vein ultrasound and transthoracic echocardiography.
• Jugular vein thrombosis.
• Superior vena cava syndrome.
• Placement of jugular vein catheter.
• Body mass index (BMI) greater than 30.0 kg/m2.
• Patients with contraindications to the use of muscle relaxants.
• Patients with lung hyperinflation and pleural effusion.
• Drop out criteria:
• Patients who wish to withdraw from the study.
• Post-anesthesia induction complications and emergencies.
• Transthoracic echocardiography provides a less representative image due to difficult acoustic window.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• Dita Aditianingsih

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD, Anesthesiologist Consultant

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: June 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: September 5, 2023
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

ID (1)