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Clinical Trials/CTRI/2024/04/065635
CTRI/2024/04/065635Not yet recruitingPhase 2/3

Bronchial Artery Embolization in the Management of Hemoptysis

DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES JAWAHARLAL NEHRU MEDICAL COLLEGE1 site in 1 country75 target enrollmentStarted: April 23, 2024Last updated:
Conditions

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
75
Locations
1
Primary Endpoint
Clinical improvement of symptoms

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Clinical improvement of symptoms

Time Frame: 1 month 6 months

Secondary Outcomes

  • NA(NA)

Investigators

Sponsor
DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES JAWAHARLAL NEHRU MEDICAL COLLEGE
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Sudhanshu Tonpe

Datta Meghe Institute of Higher Education Research

Study Sites (1)

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