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临床试验/NCT05425875
NCT05425875已完成不适用

A Randomized Controlled Trial to Compare Procedural Yield of Bronchoalveolar Lavage Using Three Different Techniques in Subjects Undergoing Flexible Bronchoscopy

Post Graduate Institute of Medical Education and Research, Chandigarh4 个研究点 分布在 1 个国家目标入组 942 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
942
试验地点
4
主要终点
To compare proportional procedures in which we obtain optimal yield

研究概览

简要总结

Bronchoalveolar lavage (BAL) via flexible bronchoscopy is a method used to sample the cellular and microbiological components of the alveolar space. It is a procedure in which 2-3 measured aliquots of sterile normal saline are instilled after wedging the scope to the suitable segmental bronchus. BAL is performed from the segments/ lobes showing ground-glass opacities (GGO), tree-in-bud lesions or focal consolidations guided by HRCT. In diffuse lung involvement, BAL is performed either from RML or the lingula.[3] It is recovered through the bronchoscope via different suction methods so as to get a sample of epithelial lining fluid of small airways and alveoli. Either manual suction or wall suction can be used for aspiration of fluid during BAL. The fluid recovered is then sent for cytology and microbiology examination studies including AFB, MGIT, GeneXpert, Galactomannan, fungal cultures to diagnose various conditions like PAP, eosinophilic pneumonia, bacterial or fungal infections, specific forms of ILD.

Three techniques have been described to perform BAL. To the best of our knowledge no previous study has compared the three methods of obtaining the BAL in the same cohort of subjects.The authors believe that the procedural yield of BAL will be best by manual suction using rubber tubing compared to manual suction without rubber tubing or wall suction. Herein, the investigators compare the three methods of obtaining BAL in subjects undergoing BAL for various respiratory diseases

详细描述

Bronchoalveolar lavage (BAL) via flexible bronchoscopy is a method used to sample the cellular and microbiological components of the alveolar space. It is a procedure in which 2-3 measured aliquots of sterile normal saline are instilled after wedging the scope to the suitable segmental bronchus. BAL is performed from the segments/ lobes showing ground-glass opacities (GGO), tree-in-bud lesions or focal consolidations guided by HRCT. In diffuse lung involvement, BAL is performed either from RML or the lingula.[3] It is recovered through the bronchoscope via different suction methods so as to get a sample of epithelial lining fluid of small airways and alveoli. Either manual suction or wall suction can be used for aspiration of fluid during BAL. The fluid recovered is then sent for cytology and microbiology examination studies including AFB, MGIT, GeneXpert, Galactomannan, fungal cultures to diagnose various conditions like PAP, eosinophilic pneumonia, bacterial or fungal infections, specific forms of ILD Normal BAL cellular components are specified as: Alveolar macrophages (AM) 85%, Lymphocytes 5-15%, Neutrophils <= 3%, eosinophils <1%. The presence of squamous epithelial cells indicates contamination by oropharyngeal secretions. [4] Additionally, BAL can be a tool for pulmonary toilet in rare diseases such as pulmonary alveolar proteinosis by helping to remove the abnormal surfactant material that accumulates with this disease.

Manual suction: It can be done using the same syringe used for instillation of the normal saline. At least 100 ml normal saline should be instilled while performing BAL and should not exceed 200 ml.

According to the studies, Modification of the manual suctioning technique (by connecting small tubing attached to syringe) provides higher percentage of BAL fluid [5].

Wall suction: During suctioning the instilled fluid, negative pressure is applied using continuous wall suction. The pressure should be <100mmHg or should be adjusted to prevent airway collapse.[6] In a study conducted by Aruna D. Herath[7], 73 pediatric patients were enrolled for a RCT undergoing flexible bronchoscopy and BAL. Two different suctioning techniques were compared for % of BAL fluid recovery. Sterile normal saline according to 1ml/kg was instilled and 100-150mmHg of negative pressure was applied for wall suction method. Thus it concluded that wall suction had better BAL fluid recovery than handheld syringe suction. Diagnostic yield was the same for both techniques.

Luis M. Seijo[8], conducted a prospective randomized study of total 220 patients undergoing BAL. Study comparing manual and wall suction in performance of BAL resulted that manual aspiration is superior to wall suction yielding larger quantity of BAL. Additionally, extra tubing with 50 ml syringe was added in manual suction technique and 50mmHg negative pressure was used in wall suction method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

盲法说明

Investigator will be blinded to the group allotment

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing BAL procedure for various indications using flexible bronchoscopy

排除标准

  • Hemodynamic instability (SBP <90mmHg , Baseline Sp02 <92% on room air)
  • Failure to provide informed consent
  • Platelet count <20,000 per mm3
  • Pregnancy
  • Subjects already enrolled in any other study

结局指标

主要结局

To compare proportional procedures in which we obtain optimal yield

时间窗: 1 hour (during bronchsocopy)

optimal yield will be defined if there is at least 30% return of volume instilled and adequate sample (\<5% bronchial cells)

次要结局

  • Diagnostic yield of BAL(1 month)
  • Percentage and volume of BAL fluid(1 hour (during bronchsocopy))
  • Proportion of subjects experiencing complications in each arm(1 month after the procedure)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Inderpaul singh

Assistant Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (4)

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