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临床试验/NCT06586060
NCT06586060尚未招募不适用

Lung Ultrasound Guided Fluid Balance Strategy in Patients with Lung Contusion

Assiut University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
PaO2/FiO2 ratio

研究概览

简要总结

Lung contusion is caused by blunt chest trauma, explosion injuries or a shock wave associated with penetrating trauma. These injuries damage alveolar capillaries, so blood and other fluids accumulate in the lung tissue. The excess fluid interferes with gas exchange leading to hypoxia To find out whether lung ultrasound as a non-invasive tool can be used to tailor the better fluid balance strategy to achieve higher oxygenation compared to other conventional methods in patients with lung contusion.

The study will evaluate a fluid management protocol for adult patients, based on the daily assessment of B-line score (BLS) using lung ultrasound, compared to usual care. A pre-specified BLS cut-off value of 15 will be used in this study to correct fluid overload After enrolment, patients were randomly assigned to BLS-guided fluid management (active group) or standard care (control group) in a 1:1 ratio, using a computerised random-number generator.

lung ultrasound guided fluid management based on BLS assessment will be conducted within 24 hours of icu admission and daily thereafter until icu discharge or for up to 14 days after randomization which ever comes first In the active group, with every LU examination, patients will be stratified into four classes: no EVLW increase (BLS = 0-4), mild increase (BLS = 5-14), moderate increase (BLS = 15-29), or severe EVLW increase (BLS ≥ 30).

In patients with no or mild EVLW increase (BLS = 0-14), a zero fluid balance (FB) will be targeted if no signs of shock are present. In patients with a moderate or severe increase in EVLW (BLS ≥ 15), a daily negative FB of -250 to -1000 mL will be targeted until BLS drops under 15. To reach daily targeted FB, furosemide-induced diuresis and RRT will be used. Furosemide will be administrated in a stepwise manner considering the previous furosemide dose and the FB achieved. If the targeted FB is achieved from the first day of diuretic administration, the furosemide dose will be maintained. If FB is outside the targeted range, the furosemide dose will be progressively reduced or increased until the goal is achieved. RRT will be used in patients with moderate and severe EVLW increase (BLS ≥ 15) if the targeted FB cannot be reached despite using the maximum furosemide dose of 800 mg/day.

In case of shocked patients with BLS < 15: they will receive fluid boluses and packed RBCs to achieve a Hb of 10 and a MAP of >65 mmHg.

In case of shocked patients with BLS ≥ 15: they will start norepinephrine infusion to reach a MAP of >65 mmHg.

In the control group, fluid management will be guided to maintain an adequate intravascular volume while minimising weight gain. Various parameters will be used to attain this goal based on case-by-case clinical judgment: lung sounds, heart rate, blood pressure, temperature, urine output, FB, lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values

Research outcome measures:

  1. Primary (main):

Difference in p-f ratio between the two groups to find out the best strategy for fluid balance for best p-f ratio. 2. Secondary (subsidiary):

Duration of ventilation Duration of ICU stay Duration of hospital stay

详细描述

Lung contusion is caused by blunt chest trauma, explosion injuries or a shock wave associated with penetrating trauma. These injuries damage alveolar capillaries, so blood and other fluids accumulate in the lung tissue. The excess fluid interferes with gas exchange leading to hypoxia. The pathophysiology of lung contusion includes ventilation / perfusion mismatching, increased intrapulmonary shunting, increased lung water, segmental lung damage, and a loss of compliance.

Fluid replacement is required to ensure adequate blood volume, but this should be done carefully as fluid overload can worsen pulmonary edema, which may be damaging. There may be wheezing, coughing, bronchorrhea and blood-streaked sputum in up to half of cases. There may be hypotension and reduced cardiac output.

Pulmonary contusion results in bleeding and fluid leakage into lung tissue, which becomes rigid and loses its normal elasticity. The water content of the lung increases over the first 72 hours after injury, and may lead to frank pulmonary edema in more serious cases.

Recently lung ultrasound has emerged as golden tool asses over hydration through the B -LINES score Lung ultrasound has the advantages of being safe, non-invasive and already part of different diagnostic algorithm of life threatening conditions with real time detection of increased extravascular lung water and providing a valuable safety threshold to conduct fluid therapy and optimize volume status.

Aim of the study:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • poly trauma patients with lung contusion
  • isolated lung contusion
  • blunt chest trauma associated with lung contusion

排除标准

  • patient refusal
  • age less than
  • Patients with known pulmonary conditions that interfere with interpretation of LUS eg: pulmonary fibrosis ,persistent pleural effusion and pnemonectomy

结局指标

主要结局

PaO2/FiO2 ratio

时间窗: once daily at 10 a.m. for 14 days after randomization

obtained from arterial blood gases

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibraheem Abdelmageed

lecturer

Assiut University

研究点 (2)

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