Clinical trial NCT06726668: Estimating Fluid Requirement in Shocked Traumatic Patients by US on SCV
Official title: Evaluation of the Role of Ultrasonographic Subclavian Vein Collapsibility Index in Estimating Fluid Requirement in Shocked Traumatic Patients in Emergency Department at Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shock
Trauma
Keywords: Us
Subclavian vein
Shock
Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Total coverage sample of all traumatic patients who will be admitted to emergency department Assiut university who fulfill the inclusion criteria during study period of 12 months from 1st of March 2025 to 1st of March 2026.

Brief summary: Research question Is the ultrasonographic SCV collapsability index effective in estimating fluid requirements in shocked traumatic Patients ?

Purpose of the study To evaluate the effectiveness of ultrasonograghic SCV collapsibility index before and after the first hour of resuscitation in estimating the First 24 h of fluid requirement in shocked traumatic patients.

Detailed description: Hypovolemic shock is a circulatory malfunction associated with inadequate tissue perfusion that leads to multi organ failure. Since it results from either blood Loss or extracellular fluid loss, quick onset hypovolemia is usually the cause. Blood loss-related hypovolemic shock is known as hemorrhagic shock. Hemorrhagic shock is typically the primary cause of shock in trauma victims, while numerous other conditions can also contribute to shock. Hemorrhage accounts for 30 to 40% of trauma-related deaths, of which 33 to 56% happen in the prehospital phase and over 40% happen in the first 24 h. This means that it can be lethal very quickly. Hematocrit levels, biochemical markers, physical examination results, and other conventional measures are used to identify hypovolemia, but are not precise markers or trustworthy since they can be deemed normal when the body's compensatory mechanisms kick in, which could cause delays in the identification of volume loss. While tachycardia is a symptom of acute fluid loss, its sensitivity and specificity are insufficient for diagnosis or monitoring because it can be altered by a variety of internal and external signals. As A central line is an invasive procedure with potential complications (venous thrombosis, infection, pneumothorax, arterial puncture) during or after the procedure and poor predictive value, measurement of CVP is not practically used in hypovolemic patients admitted to the emergency department (ED). Focused assessment with sonography for trauma (FAST) has shown to be an effective way to identify bleeding sites in trauma patients using sonography. FAST took an average of 4 min per patient and was used successfully as a primary screening procedure at the hospital's entrance for traumatized mass casual patients. However, it provides no information regarding the patient's hemodynamic status, blood loss, amount lost, or response to resuscitation. As such, we require techniques for early detection of hypovolemia and accurate follow-up. The use of ultrasonography in critical care has grown in recent years due to technological advancements. The SCV is widely acknowledged as a trustworthy metric for assessing hemodynamic conditions. When the body experiences volume loss, the compensatory vasoconstrictor reaction has little effect on the SCV diameter. The noninvasive quick diagnosis, and low cost of sonographic measurement Of SCV diameter make this method a valuable tool for determining fluid requirements and evaluating Volume status in critically ill patients.

Eligibility criteria: Inclusion Criteria:

* Traumatic patients who will come to emergency department at Assiut university Hospital between march 2025 to march 2026 and will be admitted after stabilization to the Inpatient ward or ICU

Exclusion Criteria:

* Patients or their Relatives refuse participation in the study.

  * Patients who will be transferred to another hospital

    * • Pregnant women.
  * Age below 18 and more than 60.
  * Failure of follow-up of any patient.
  * Cardiopulmonary resuscitation on arrival.
  * Contraindicating fluid challenges, such as cardiac insufficiency and Renal failure .

Primary outcomes:
measure: To estimate and predict the fluid requirement using ultrasonograghic Sub Clavian vein collapsibility index before and after the first hour of resuscitation
timeFrame: Before resuscitation and after 1 hour of resuscitation
Secondary outcomes:
measure: To estimate and predict the First 24-h fluid requirement using repeated ultrasonograghic SCV collapsibility index.
timeFrame: In the first 24 hours of resuscitation
measure: -To assess the role of ultrasonograghic SCV CI in rapidly detecting early shock stages.
timeFrame: In the first 24 hours of resuscitation
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
name: Mohamed A Mohamed Abdelhameed, Resident
role: PRINCIPAL_INVESTIGATOR
References: