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临床试验/NCT06678035
NCT06678035尚未招募不适用

Use of Simplified Lung Ultrasound Score for Predicting ICU Outcomes in Patients with Acute Respiratory Failure

Assiut University0 个研究点目标入组 72 人开始时间: 2024年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
主要终点
ICU Mortality

研究概览

简要总结

This study aims to

Primary Aims:

Verify the predictability of the PLIS at admission in predicting major clinical outcomes including:

  • ICU mortality (or discharge) and time to death (or discharge)
  • Escalation of ventilatory support antibiotic therapy or supportive medications (inotropes, steroids, sedation, neuromuscular blockers).

Secondary Aims:

  • Determine the correlation between initial PLIS and the degree of disease severity (as evaluated per SOFA and APACHE II scores)
  • Determine the correlation between initial PLIS and partial pressure of oxygen in arterial blood (PaO2) to Fraction of inspired oxygen (FiO2): PaO2/FiO2
  • Explore the potential association between the type of ventilatory support, ventilatory settings and PLIS at different time points.
  • Verify whether the site of consolidation (anterior vs. posterior lung zones) can reliably predict mortality in in ALI patients.
  • Determine the correlation between the PLIS score and the degree of ALI as quantified by CT of the chest (whenever a CT study is available) at the time of admission.

详细描述

Respiratory failure and acute lung injury (ALI) in patients admitted to ICU are major causes of morbidity And mortality As high as 60 % of ICU population dii during their ICU admission due to ALI Accurate assessment of the severity of ALI is Crucial for guiding treatment decisions and predicting patient outcome Reliance on chest X-ray and Computed tomography has its limitations including subjectivity and potential delays in obtaining and interpreting results high cost radiation exposure and lack of continuous monitoring particularly for critically ill patients Ultrasound -being non-invasive low cost radiation free- has been increasingly used as a bedside tool for evaluation and monitoring of ALI However most lung ultrasound protocols published to date are cumbersome and time consuming They typically involve screening at least 12 different lung areas each graded from 0 to 3 point thus generating scores ranging from 0 to 36 .While these scores are informative for research purposes they are less practical in a busy or ICU environment Also disregarding the site of B-lines or consolidation and the size of consolidation potentially under-estimates the severity of ALI Recently a novel -yet comprehensive- point of care ultrasound lung injury score has been developed to aid informative and quick assessment of ALI in ICU PLIS involves screening of only 3 areas but it uniquely considers the level of ventilatory support and gives credit to the number of B lines size of consolidation location of consultation The score reliably predicted to the need of ICU admission in a group off of COVID 19 patients directly correlation with their SOFA scores also predicted ICU mortality in this patient However Wider adoption of PLIS by intensivists dictates evaluation of its performance in a wider ICU population with a variety of underlying diagnoses This study is to verify whether PLIS remains valid for predicting ICU outcomes in patients with acute respiratory failure regardless the etiology type of respiratory failure oxygen requirement level of ventilatory support

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age is or more than 18 years old.
  • Admission to ICU in the first24 hours at time of recruitment to the study.
  • Patients in respiratory failure [PaO2 is less then 60 % mmHg]

排除标准

  • Co- existing chronic lung disease, pathology of which is known display abnormalities on US examination (interstitial lung diseases, bronchiectasis).
  • Large pneumothorax or massive pleural effusion causing significant collapse and precluding proper visualization of underlying lung.
  • Conditions that may interfere with lung ultrasound quality or probe contact such as marked obesity, severe chest wall deformities, burns or wounds.

结局指标

主要结局

ICU Mortality

时间窗: 60 days

Percentage of patients who will die during their ICU admission

Time to death/discharge

时间窗: 60 days

Number of days until the patient dies inside the ICU or becomes discharged from ICU

次要结局

  • Need for Therapy escalation: Ventilatory Support(60 days)
  • Need for Therapy Escalation: Ventilatory seetings(60 days)
  • Need for Therapy Escalation: Medications(60 days)

研究者

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

Mona Zakaria Hassab Elnabi Shahin

Resident doctor Principal investigator

Assiut University

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