Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Hemorrhagic shock from severe bleeding is a leading cause of preventable death in trauma patients. Intravenous (IV) fluid resuscitation is essential for stabilizing blood pressure and organ perfusion, but administering too much or too little fluid can cause severe complications. Only about half of hemodynamically unstable patients show an increase in cardiac output after receiving fluids. Emergency physicians often use bedside ultrasound to measure respiratory changes in the inferior vena cava (IVC), known as the IVC collapsibility index (IVC-CI), to predict whether a patient will benefit from fluids. However, obtaining clear IVC views can be difficult or impossible in trauma patients due to abdominal pain, obesity, or abdominal injuries. Evaluating the subclavian vein (SCV) under the collarbone provides a potential alternative window.
The main purpose of this study is to compare the diagnostic accuracy of the subclavian vein collapsibility index (SCV-CI) against the inferior vena cava collapsibility index (IVC-CI) for predicting fluid responsiveness in adult trauma patients presenting with hemorrhagic shock.
Eligible adult trauma patients with hemorrhagic shock will undergo rapid bedside point-of-care ultrasound upon presentation to the emergency department. Physicians will measure respiratory diameter variations in both the subclavian vein and inferior vena cava. Patients will then receive a standardized fluid challenge of 10 mL/kg intravenous balanced crystalloid solution over 10 to 15 minutes as part of resuscitation. Fluid responsiveness will be assessed by measuring changes in blood flow through the neck using carotid artery Doppler ultrasound before and 5 to 10 minutes after the fluid challenge. The study will determine whether subclavian vein ultrasound offers comparable diagnostic performance and greater feasibility compared to inferior vena cava ultrasound in emergency trauma resuscitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older.
Presentation with blunt or penetrating trauma.
Clinical evidence of hemorrhagic shock, defined by hypotension (systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg), tachycardia, or other clinical signs of tissue hypoperfusion requiring fluid resuscitation.
Spontaneously breathing patients.
Disqualifiers
Age younger than 18 years.
Pregnancy.
Requirement for immediate endotracheal intubation and mechanical ventilation prior to ultrasound assessment.
Obstructive shock due to cardiac tamponade, tension pneumothorax, or other known causes.
Trial population
Adult trauma patients aged 18 years or older presenting with blunt or penetrating trauma and clinical evidence of hemorrhagic shock (systolic blood pressure \< 90 mmHg, mean arterial pressure \< 65 mmHg, or clinical signs of tissue hypoperfusion) to the Emergency Department of Assiut University Trauma and Emergency Hospital within 6 hours of injury.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 1 trial groupGroup A: Adult Trauma Patients with Hemorrhagic Shock
Trial outcomes
Primary outcomes
1
Area Under the Receiver Operating Characteristic Curve (AUC) of Subclavian Vein Collapsibility Index (SCV-CI)
The area under the receiver operating characteristic curve (AUC-ROC) will be calculated to determine the diagnostic accuracy of baseline SCV-CI for predicting fluid responsiveness. Fluid responsiveness is defined as an increase of ≥ 15% in carotid artery velocity time integral (Carotid VTI) following a 10 mL/kg crystalloid bolus. AUC values range from 0.5 (no discriminative ability) to 1.0 (perfect diagnostic accuracy).
Time frame
10 minutes post-fluid challengeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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