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临床试验/NCT05370664
NCT05370664尚未招募不适用

Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study

Assiut University0 个研究点目标入组 203 人开始时间: 2022年7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
203
主要终点
Mortality rate among COPD patients hospitalized due to acute exacerbation.

研究概览

简要总结

  • Assess predictors of mortality in COPD exacerbation between men and women.
  • Evaluate the clinical outcomes in acute exacerbation of COPD in women.
  • Evaluate the validity of new scoring systems ( NIVO, DECAF, HACOR ) as a predictor for hospital outcome in acute exacerbation of COPD.
  • Compare these new scoring system with the most widely used APACHE IV.
  • Assessment of serum level of granulocyte colony stimulating factor ( GM-CSF) in detecting the severity of COPD exacerbation.

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
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with AECOPD leading to hypoxemia, hypercapnia and respiratory acidosis with pH < 7.35 and PaCO2 > 45 mm of Hg will be admitted to the respiratory intensive care unit (ICU) for NIV or the ward will be eligible for inclusion and not in need for mechanical ventilation

排除标准

  • •Requirement for emergency intubation.
  • •Other contraindications to NIPPV including cardiac or respiratory arrest; nonrespiratory organ failure (eg, severe encephalopathy, severe gastrointestinal bleeding, hemodynamic instability with or without unstable cardiac angina); facial surgery or trauma; upper-airway obstruction; inability to protect the airway and/or high risk of aspiration; and inability to clear secretions.(6)
  • •Age < 35 years.

结局指标

主要结局

Mortality rate among COPD patients hospitalized due to acute exacerbation.

时间窗: 28 days from admissiom

Assessment of mortality with different scoring systems in acute exacerbation of COPD

Early prediction of NIV failure.

时间窗: 48 hours from ICU admission

Using NIVO score for Acute exacerbaion of COPD Non-invasive ventilation outcomes score is considered to be Low risk ( 0-2) Moderate risk (3-4) High risk (5-6) Very high risk ( 7-9)

Assessment of GM-CSF as a biomarker for successful therapy in acute exacerbation of COPD.

时间窗: baseline

Assessment of granulocyte colony stimulating factor by ELISA test in acute exacerbation of COPD

次要结局

  • Assisted ventilation days.(Baseline)

研究者

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

Khaled Essmat Hussien

Assistant Lecturer of chest diseases and tuberculosis

Assiut University

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