Clinical trial NCT05930600: Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns As Predictors of Fluid Responsiveness
Official title: Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns As Predictors of Response to Fluid Administration in Elective Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Hemodynamic Monitoring
Keywords: Internal Jugular Venous Distensibility Index
Innominate Venous Flow Patterns
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: IJV distensibility index correlation to fluid responsiveness
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of IJV distensibility index in fluid responders and non-fluid responders.
timeFrame: 1 day
measure: Detection of sensitivity, specificity, positive predictive value, negative predictive value, and best cut off value of IJV distensibility index to predict fluid responsiveness
timeFrame: 1 day
measure: Correlation of IJV distensibility index and stroke volume
timeFrame: 1 day
measure: Innominate vein flow velocity correlation to fluid responsiveness
timeFrame: 1 day
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Rumah Sakit Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Dita Aditianingsih
role: PRINCIPAL_INVESTIGATOR
References: