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临床试验/CTRI/2024/04/065635
CTRI/2024/04/065635尚未招募2/3 期

Bronchial Artery Embolization in the Management of Hemoptysis

DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES JAWAHARLAL NEHRU MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年4月23日最近更新:
适应症

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
Clinical improvement of symptoms

研究概览

简要总结

STUDY DESIGN:Prospective observational study. TIME FRAME / DURATION: 2YEARS METHODOLOGY: The study will be conducted after approval from the institutional ethical committee in our institution, a tertiary care hospital, for two years. Patients presenting with massive Hemoptysis referred to our department will be included for bronchial artery embolization. Massive Hemoptysis is defined as bleeding more than 600ml / 24 hr. All patients will have a chest x-ray to lateralize the side of the bleeding. HRCT thorax will be done in some patients to know further about the lesions and bronchial and non-bronchial feeders before embolization. SAMPLE SIZE CALCULATION : Expected Sensitivity: 0.97 (13) Expected specificity: 0.91 (13) Prevalence of disease: 0.30 (14) Precision (± expected): 0.08 Confidence level 100(1- α): 95% Expected dropout rate: 5% Final Sample size (with 5% dropout) = 75 Statistical Analysis Data will be entered into a Microsoft Excel sheet, and statistical analysis will be done on the statistical software STATA 12. For descriptive statistics, mean ± standard deviation will be used, a median and interquartile range for quantitative variables, and a percentage with a number for categories. The relationship between various demographic, clinical characteristics and echocardiography diagnoses with the outcome will be evaluated by deploying the Chi-square test, Fischer’s exact test for categorical data, and an independent t-test for continuous data with normal distribution. Spearman (parametric) or Pearson (non-parametric) correlations will be applied to determine the association between dependent and independent variables. The p-value will be considered significant if less than 0.05.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • The potential candidate for BAE is a patient meeting any of the following criteria:
  • Hemoptysis >200ml /h or 600 ml /24 hrs
  • Hypovolemia due to acute Hemoptysis with systolic BP 90 mm hg.
  • Respiratory failure due to acute Hemoptysis requiring endotracheal intubation and mechanical ventilation.

排除标准

  • Patients not giving consent for the procedure.
  • Patients having deranged coagulation profile.
  • Patients declared unfit on pre-anaesthetic checkups due to co-morbidities
  • Pregnant patients.
  • Allergic to contrast media
  • Deranged KFT.

结局指标

主要结局

Clinical improvement of symptoms

时间窗: 1 month 6 months

次要结局

  • NA(NA)

研究者

发起方
DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES JAWAHARLAL NEHRU MEDICAL COLLEGE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sudhanshu Tonpe

Datta Meghe Institute of Higher Education Research

研究点 (1)

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