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

Fluid Responsiveness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930600
• Other study ID #: IndonesiaUAnes044
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: June 2023
• Source: Indonesia University
• Contact: Dita Aditianingsih
• Phone: +618151819244
• Email: ditaaditiaa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Responsiveness
• Hemodynamic Monitoring

Intervention

Device:
• Ultrasonography of Internal Jugular Vein
Non invasive monitoring of fluid responsiveness
• Doppler Echocardiograhy
Non invasive monitoring of fluid responsiveness

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of IJV distensibility index in fluid responders and non-fluid responders.		1 day
Secondary	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
Secondary	Correlation of IJV distensibility index and stroke volume		1 day
Secondary	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