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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05930600
Other study ID # IndonesiaUAnes044
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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