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临床试验/NCT06477861
NCT06477861招募中不适用

The Role of Elastic Power in Predicting the Severity and Mortality in Adult Patients With Acute Respiratory Distress Syndrome Secondary to Pneumonia

Benha University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
28 day mortality

研究概览

简要总结

the role of elastic power in the prediction of severity and mortality in adults with ARDS secondary to pneumonia

详细描述

Acute respiratory distress syndrome (ARDS) is an acute inflammatory pulmonary disease due to an acute damage of the alveoli, being the most common acute and critical illnesses in intensive critical care medicine.

The international epidemiological LUNGSAFE study shows that the incidence of ARDS in the ICU is approximately 10%, and the mortality rate is still as high as 30-50%, representing a major medical problem facing the society at present .

The Berlin criteria underwent a significant improvement in 2012, and the severity of the disease is graded according to the oxygenation index as compared with the previous ARDS American-European Consensus Conference (AECC) definition .

However, the further research on ARDS in the past ten years revealed that the Berlin standard also has some limitations .

First, investigations found that early oxygenation index (PaO2/FiO2 ratio) may not fully reflect the severity of lung disease in ARDS patients due to the different phases of ARDS progression and the distinctive responses to oxygenation strategy in diseased lung tissues.

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 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 65 years (male or female). Patients fulfilling criteria of ARDS as per Berline definition who will be admitted to ICU , intubated and MV more than 48 hours will be included in this study.
  • Fulfillment of Criteria of readiness for ARDS as per Berline definition :
  • an acute onset (<1 week of a known clinical insult or new or worsening respiratory symptoms),
  • respiratory failure not primarily due to hydrostatic edema,
  • bilateral opacities on a chest radiograph (not fully explained by effusions, lobar or lung collapse, or nodules), and
  • <300 mmHg of the ratio of arterial partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2/FiO2) with 5 cm H2O of positive end-expiratory pressure (PEEP) or continuous positive airway pressure. To facilitate the estimation of the ARDS prognosis, the Berline definition classifies the severity of ARDS into 3 categories: mild (200 mmHg < PaO2/FiO2 < 300 mmHg), moderate (100 mm Hg < PaO2/FiO2 <200 mmHg), and severe (PaO2/FiO2 < 100 mmHg).

排除标准

  • Non intubated ICU admissions
  • Non-invasive ventilated patients.
  • Age less than 18 years or more than 65 years of age
  • Open chest wall trauma.
  • Patient requiring Extra Corporal Membrane Oxygenator
  • Patients with increased intrabdominal pressure interfering with mechanical ventilator parameters measurements

结局指标

主要结局

28 day mortality

时间窗: 28 days

- survivors are defined as patients who are discharged from ICU or survive beyond 28 days

次要结局

  • elastic power normalized to compliance(28 days)

研究者

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

Ahmed Hossameldin Ahmed Awad

principle investigator

Benha University

研究点 (1)

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