Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Comparison of Inferior Vena Cava Versus Subclavian Vein Collapsibility Indices for Prediction of Fluid Responsiveness in Adult Trauma Patients Presenting With Hemorrhagic Shock: A Prospective Comparative Cohort Study
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.
연구 개요
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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.
- Presentation to the Emergency Department within 6 hours of injury.
- Feasibility of bedside point-of-care ultrasound examination prior to the initiation of definitive resuscitation.
Exclusion Criteria:
- 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.
- Known severe heart failure with left ventricular ejection fraction (LVEF) < 40%.
- Significant tricuspid regurgitation or known pulmonary hypertension that may affect systemic venous measurements.
- Major neck or clavicular trauma preventing adequate subclavian vein ultrasound acquisition.
- Extensive abdominal trauma, morbid obesity, or other conditions precluding adequate inferior vena cava (IVC) acoustic visualization.
- Transfer from another facility after receiving large-volume fluid resuscitation (> 1 L of crystalloids or blood products prior to assessment).
- Inability or refusal to provide informed consent by the patient or their legally authorized representative.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Adult Trauma Patients with Hemorrhagic Shock
Spontaneously breathing adult trauma patients (aged ≥ 18 years) presenting to the Emergency Department within 6 hours of blunt or penetrating injury with clinical evidence of hemorrhagic shock (SBP < 90 mmHg or MAP < 65 mmHg, tachycardia, or tissue hypoperfusion).
All enrolled participants undergo baseline point-of-care ultrasound examination to measure both the inferior vena cava collapsibility index (IVC-CI) and subclavian vein collapsibility index (SCV-CI), in addition to carotid artery velocity time integral (Carotid VTI).
Following baseline ultrasound, participants receive a standardized fluid challenge of 10 mL/kg intravenous balanced crystalloid over 10-15 minutes.
Carotid VTI is remeasured within 5-10 minutes post-infusion to evaluate fluid responsiveness (defined as a Carotid VTI increase ≥ 15%).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Area Under the Receiver Operating Characteristic Curve (AUC) of Subclavian Vein Collapsibility Index (SCV-CI)
기간: 10 minutes post-fluid challenge
|
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).
|
10 minutes post-fluid challenge
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IVC vs SCV for Fluid Response
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .