跳至主要内容
临床试验/NCT05400343
NCT05400343Unknown不适用

Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury

Mansoura University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
72
试验地点
2
主要终点
Cumulative Fluid balance

研究概览

简要总结

Traumatic brain injury (TBI) is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed, management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia and maintaining appropriate cerebral perfusion pressure (CPP), which is a surrogate for cerebral blood flow (CBF). The goal should be euvolemia and avoidance of hypotension. The assessment of a patient's body fluid status is a challenging task for modern clinicians.

The use of Ultrasonography to assess body fluids has numerous advantages. The concept of using lung ultrasound for monitoring the patient is one of the major innovations that emerged from recent studies. Pulmonary congestion may be semiquantified using lung ultrasound and deciding how the patient tolerates fluid. Inferior vena cava (IVC) sonography and point-of-care ultrasound (POCUS) has become widely used as a tool to help clinicians prescribe fluid therapy. Common POCUS applications that serve as guides to fluid administration rely on assessments of the inferior vena cava to estimate preload and lung ultrasound to identify the early presence of extravascular lung water and avoid fluid over resuscitation In this study we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI. We will also use ONSD as a mirror for intra-cranial pressure (ICP).

详细描述

The aim of this study is to detect the effectiveness of using IVC and lung ultrasound as bedside tools to ensure euvolemia in patients with traumatic brain injuries

Positive fluid balances have been associated with (angiographic) vasospasm, longer hospital length of stay and poor functional outcomes The assessment of a patient's body fluid status is a challenging task for modern clinicians. Currently, the most accurate method to guide fluid administration decisions uses "dynamic" measures that estimate the change in cardiac output that would occur in response to a fluid bolus. Unfortunately, their use remains limited due to required technical expertise, costly equipment, or applicability in only a subset of patients. Alternatively, point-of-care ultrasound (POCUS) has become widely used as a tool to help clinicians prescribe fluid therapy.

International recommendations suggest that the inferior vena cava (IVC) can be assessed to estimate the pressure in the right atrium of non-ventilated patients because of its collapsibility during inspiration. An IVC diameter of < 21mm with collapsibility of > 50% during inspiration suggests normal right atrium pressure (between 0 and 5 mmHg), whereas a diameter of > 21mm with collapsibility of < 50% suggests high pressure (between 10 and 20mmHg). The dynamic method of IVC evaluation, based on the variation in its diameter with respiration, enables the assessment of the potential benefit of fluid administration as a function of IVC compliance.

Ultrasonography of optic nerve sheath diameter (ONSD) in TBI patients has been shown to correlate with increased ICP and systemic reviews have supported this observation.

In this study, we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI. We will also use ONSD as a mirror for ICP

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

Single-blind (participant) study

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI less than 35 kg/m2
  • Diagnosed with traumatic brain injury
  • Glasgow coma score ≥ 4

排除标准

  • Inability to get consent
  • Presence of Increased intra-abdominal pressure,
  • Presence of acute cor pulmonale
  • Presence of severe right ventricular dysfunction.
  • Pregnancy
  • Patients with known pulmonary conditions that interfere with the interpretation of lung ultrasound like pneumectomy; pulmonary fibrosis; persistent pleural effusion
  • Stage 5 chronic kidney disease
  • indication for emergency renal replacement therapy (RRT)

结局指标

主要结局

Cumulative Fluid balance

时间窗: 10 days or until ICU discharge which comes first.

The difference between patient fluid intake and patient fluid output is recorded every 24 h then the cumulative balance is recorded

次要结局

  • ONSD as mirror for intracranial pressure.(every other day for 10 days or until ICU discharge which comes first)
  • Urine output(10 days or until ICU discharge which comes first)
  • Frequency of hypotension(every other day for 10 days or until ICU discharge which comes first)
  • Duration of hypotension(10 days or until ICU discharge which comes first)
  • Serum creatinine(10 days or until ICU discharge which comes first)
  • Incidence of pulmonary edema(10 days or until ICU discharge which comes first)
  • Length of mechanical ventilation(10 days or until ICU discharge which comes first)
  • Mortality at 10 days(mortality at day 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验