跳至主要内容
临床试验/NCT05980494
NCT05980494已完成不适用

Validity of Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Patients: a Comparative Study

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年9月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
The sensitivity of lung ultrasound in predicting fluid responsiveness.

研究概览

简要总结

Evaluation and management of intravascular volume are a central challenge for the critical ill patients. Hypotensive patients are commonly resuscitated with intravenous crystalloid fluid as a recommendation for treatment of many shock states.

There has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade as it is easy, bedside, non-expensive, non invasive and radiation free.

The object of the current study is to assess the ability of lung and inferior vena cava sonography versus pulse pressure variation to predict fluid responsiveness in patients with circulatory failure on mechanical ventilation.

详细描述

The study will be conducted in intensive care units of Fayoum University Hospitals after approval of the local institutional ethics committee and local institutional review board. Hypotensive Patients on mechanical ventilation starting from August 2022 will be enrolled in this prospective study until fulfilling sample size. A detailed informed consent will be signed before recruitment. All patients who fulfilled inclusion criteria will be monitored by: 6 leads ECG, Blood pressure, Urinary catheter for urine output, Pulse oximter.Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study. The Consolidated standards of Reporting Trials (CONSORT) recommendation will be followed. LUS and IVC measurements were performed by using a convex ultrasound probe (Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID: 1385). LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior. Ultrasound examination of the anterolateral chest was carried out with longitudinal scan of the right and left hemi thoraces, from the second to the fourth (on the right side to the fifth) intercostal space, as previously described. For each quadrant a score will be assigned based on B lines which are defined as an echogenic artifact with a narrow origin on the pleural line, deepening to the inferior border of the screen and coherent with respiratory movements indicating subpleural interstitial edema as follows:

(0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines

  1. Moderate loss of lung aeration: well-defined, multiple B lines.
  2. Severe loss of lung aeration: multiple coalescent B lines.
  3. Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post).

IVC US: The inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter.

PPV: patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients on mechanical ventilation (MV).
  • Aged more than 18 years.
  • Mean arterial pressure (MAP) less than 65 mmHg or systolic arterial pressure less than 90mm Hg with signs of hypoperfusion (urinary flow < 0.5mL/kg/ h for > 2hr , tachycardia > 100 beats/min, or presence of skin mottling , and seurm lactate more than 2 mmol/L).

排除标准

  • Cardiac arrhythmias.
  • Previously known significant valvular disease or intracardiac shunt.
  • Chest drains.
  • Increasing intra abdominal pressure.
  • Prephiral vascular disesaes.
  • Adult respiratory distress syndrome (ARDS) patients due to low tidal volume.
  • Interstitial lung disease because B-lines in these conditions are the consequence of the thickened interlobular septa characterizing fibrosis and are not modified by the state of hydration or imbibition 12
  • Any contraindication for fluid administration as cardiogenic shock, acute pulmonary edema or LVEF% less than 50%.
  • Renal patients with oliguria and volume overload including patients on hemodialysis or patients with acute anuric renal failure.
  • Patients with lower extremity artery/vein thrombosis, significant lower extremity artery plaque, lower extremity artery occlusion, inferior vena cava filter implantation and lower extremity varicose veins.

研究组 & 干预措施

Scanning group

Experimental

Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.

干预措施: normal Saline (Drug)

Scanning group

Experimental

Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.

干预措施: lung ultrasound (Device)

Scanning group

Experimental

Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.

干预措施: inferior vena cava measurements (Device)

Scanning group

Experimental

Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.

干预措施: passive leg raising test (PLRT) (Diagnostic Test)

Scanning group

Experimental

Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.

干预措施: pulse pressure variation (Device)

结局指标

主要结局

The sensitivity of lung ultrasound in predicting fluid responsiveness.

时间窗: After 5 minutes of admission

\<0.8: non-sensitive, \>0.8: sensitive

次要结局

  • lung ultrasound B lines score(after 5 minutes of admission)
  • Inferior vena cava distensibility index.(after 10 minutes of admission)
  • pulse pressure variation(15 minutes after admission)
  • central venous pressure(after 20 minutes of admission)
  • serum lactate(after 30 minutes of admission)
  • urine output(in 1 hour after admission)
  • length of stay in ICU(1 hour after discharge)
  • specificity of lung ultrasound predicting fluid responsiveness(5 minutes after admission)
  • sensitivity of IVC ultrasound predicting fluid responsiveness(after 5 minutes of admission)
  • sensitivity of pulse pressure variation predicting fluid responsiveness(after 5 minutes of admission)
  • specificity of IVC ultrasound predicting fluid responsiveness(after 5 minutes of admission)
  • specificity of pulse pressure variation predicting fluid responsiveness(after 5 minutes of admission)
  • heart rate(5 minutes after admission)

研究者

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

Mohamed Ahmed Hamed

Associate professor

Fayoum University Hospital

研究点 (1)

Loading locations...

相似试验