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临床试验/CTRI/2025/02/080092
CTRI/2025/02/080092尚未招募不适用

The Feasibility and Diagnostic Potential Of Novel Material In Mini Bronchoalveolar Lavage and Comparison With Traditional Bronchoalveolar Lavage and Endotracheal Aspirate ( ETA )

Saveetha Medical college and hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
43
试验地点
1
主要终点
The diagnostic efficacy in Mini bal done in ICU patient who cannot undergo traditional bronchoscopy and comparing mini bal with traditional bronchoalveolar lavage and endotracheal aspirate

研究概览

简要总结

INTRODUCTION :

Respiratory infections and illnesses pose significant challenges in clinical practice and public health. Accurate diagnosis is crucial for effective treatment and control. Popular diagnostic techniques include Bronchoalveolar lavage (BAL), mini-BAL, and endotracheal aspirate (ETA). BAL is the gold standard for sampling lower respiratory tract secretions, providing valuable information for pulmonary disorders like pneumonia. Mini-BAL is less invasive and can detect ventilator-associated pneumonia but may have lower diagnostic yield. ETA is a quick, easy, and accessible non-invasive technique, but its poorer sensitivity and specificity can lead to false-negative results. This study evaluates the accuracy and safety of BAL, mini-BAL, and ETA in respiratory infection diagnosis.

NEED FOR THE STUDY :

Different methods like BAL, Mini-BAL, and ETA impact the accuracy of their diagnoses. Mini-BAL is less intrusive, while ETA aspirates secretions from the endotracheal tube. BAL allows for more focused collection, while ETA is less intrusive but may not yield a complete sample. Understanding the cost-effectiveness of these procedures is crucial for healthcare systems to optimize resource utilization and maintain diagnostic accuracy. Different respiratory diseases require different diagnostic approaches, such as BAL for infections or interstitial lung diseases and ETA for ventilator-associated pneumonia. Comparing these techniques helps clinicians make evidence-based decisions, enhancing patient care.

METHODOLOGY :

This is a prospective study done on patients hospitalized to Saveetha Medical College and Hospital’s respiratory critical care unit (ICU) with bilateral pneumonia, respiratory failure, and invasive mechanical ventilation. The infiltrates were documented using a chest X-ray in the ICU, with a CT thorax demonstrating consolidation added. In this investigation,First Group of Patients received Traditional BAL , Mini BAL ,  ETA  , while the second group was assigned to Mini-BAL, and ETA  who cannot undergo Traditional BAL . To collect ETA, a sterile suction catheter was introduced via the endotracheal tube until resistance was encountered. The catheter was removed, and samples were collected in a sterile container. Mini BAL is collected by a twin catheter technique, which involves inserting two different size suction catheters, giving sterile saline through the catheter, and aspirating with a syringe or wall mount suction via mucus trap. The bronchoscope is placed into the bronchopulmonary region, which is closed off by the bronchus, and aliquots of normal saline are injected. Bacterial tests are performed on patients. BAL, micro BAL, and aspirate are compared for organism diagnosis.

ANALYSIS OF RESULTS :

While comparing BAL, Mini-BAL and ETA helps to personalize antibiotic therapy based on preliminary microbiological data. It can help you avoid broad-spectrum .Allows for tailored antibiotic therapy, which reduces wasteful antibiotic use and the danger of antibiotic resistance. It also offers information on antimicrobial susceptibility patterns, which helps guide treatment selections

EXPECTED OUTCOME :

The expected outcome of the study is to establish high sensitivity and specificity of yield of the organism using mini bronchoalveolar lavage , at par or non-inferior to the traditional bronchoalveolar lavage .

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Ability to give consent 2.Patient who are on ventilator 3.Patients with suspected lung infections (e.g., pneumonia) 4.Patients with suspected interstitial lung diseases (e.g., sarcoidosis, idiopathic 5.pulmonary fibrosis) for diagnostic evaluation.
  • 6.Immunocompromised patients with suspected opportunistic infections (e.g., 7.Pneumocystis jirovecii pneumonia) or lung complications.
  • 8.Patients with suspected aspiration syndromes 9.Evaluation of diffuse alveolar hemorrhage in patients with known vasculitis 10.Investigation of occupational lung diseases (e.g., pneumoconiosis.

排除标准

  • 1.Age above 80 years or age less than 18 years 2.Patient who are unable to give consent 3.Patients who are hemodynamically unstable 4.Patients with uncontrolled bleeding disorders or on anticoagulant therapy where the risk of bleeding outweighs the benefits of the procedure.
  • 4.Patients with severe hypoxemia that may not tolerate the procedure well.
  • 5.Patients with significant facial or upper airway trauma or obstruction that impedes safe passage of the bronchoscope.
  • 6.Patients with known allergies to medications or materials used during the procedure.
  • 7.Patients with severe mental or neurological impairment who cannot provide informed consent.
  • 8.Patients with uncooperative behaviour or inability to follow pre-procedure instructions (e.g., fasting).
  • 9.Patients with recent myocardial infarction or stroke.

结局指标

主要结局

The diagnostic efficacy in Mini bal done in ICU patient who cannot undergo traditional bronchoscopy and comparing mini bal with traditional bronchoalveolar lavage and endotracheal aspirate

时间窗: 3 days after the procedure

次要结局

  • Helps in finding the antibiotics sensitivity early and there by reducing the resistance to antibiotics(3 days after the procedure)

研究者

发起方
Saveetha Medical college and hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rajamani K

Saveetha Medical College

研究点 (1)

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