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OpenTrials
Completed

NCT Number: NCT05930600

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ultrasonography of Internal Jugular Vein

Device

Non invasive monitoring of fluid responsiveness

Doppler Echocardiograhy

Device

Non invasive monitoring of fluid responsiveness

Primary outcomes

  1. IJV distensibility index correlation to fluid responsiveness

    Time frame: 1 day

    Correlation between IJV distensibility index and fluid responsiveness defined as increase of stroke volume more than 10% after fluid challenge

Secondary outcomes

  1. Comparison of IJV distensibility index in fluid responders and non-fluid responders.

    Time frame: 1 day

  2. Detection of sensitivity, specificity, positive predictive value, negative predictive value, and best cut off value of IJV distensibility index to predict fluid responsiveness

    Time frame: 1 day

    By ROC curve and Youden index

  3. Correlation of IJV distensibility index and stroke volume

    Time frame: 1 day

  4. Innominate vein flow velocity correlation to fluid responsiveness

    Time frame: 1 day

    Correlation between Innominate vein flow velocity and fluid responsiveness defined as increase of stroke volume more than 10% after fluid challenge

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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