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CTRI Number  CTRI/2025/02/080092 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Diagnostic 
Study Design  Other 
Public Title of Study   Comparison of Bronchoalveolar Lavage, Mini-Bronchoalveolar Lavage and Endotracheal Aspirate  
Scientific Title of Study   The Feasibility and Diagnostic Potential Of Novel Material In Mini Bronchoalveolar Lavage and Comparison With Traditional Bronchoalveolar Lavage and Endotracheal Aspirate ( ETA ) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajamani K  
Designation  Post Graduate ( junior resident )  
Affiliation  Saveetha Medical College  
Address  Room No:402, 4TH Floor Department Of Respiratory Medicine Saveetha Medical College Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105

Chennai
TAMIL NADU
600010
India 
Phone  8525893457  
Fax    
Email  drrajikasi97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Prasanth G 
Designation  Assistant Professor  
Affiliation  Saveetha Medical College  
Address  Room No:402, 4TH Floor Department Of Respiratory Medicine Saveetha Medical College Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105

Chennai
TAMIL NADU
600010
India 
Phone  9788852770  
Fax    
Email  prasanthgd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajamani K  
Designation  Post Graduate ( junior resident )  
Affiliation  Saveetha Medical College  
Address  Room No:402, 4TH Floor Department Of Respiratory Medicine Saveetha Medical College Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105

Chennai
TAMIL NADU
600010
India 
Phone  8525893457  
Fax    
Email  drrajikasi97@gmail.com  
 
Source of Monetary or Material Support  
Room No:402, 4TH Floor Department Of Respiratory Medicine Saveetha Medical College Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105  
 
Primary Sponsor  
Name  Saveetha Medical college and hospital  
Address  Room No:402, 4TH Floor Department Of Respiratory Medicine Saveetha Medical College Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRajamaniK  Saveetha Medical College and Hospital  Room No:402, 4TH Floor Department Of Respiratory Medicine Saveetha Medical College Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU 
8525893457

drrajikasi97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mini Bronchoalveolar Lavage   The initial design of Mini Bronchoalveolar lavage was done using solid work program and subsequently processed using silicone into two tubes and former into a mini Bronchoalveolar Lavage instrument.  
Comparator Agent  Traditional Bronchoalveolar Lavage and Endotracheal Aspirate   Traditional Bronchoalveolar Lavage is done via bronchoscopy to obtain sampling from the bronchopulmonary section, and et aspirate is done in all intubated patients, which is less invasive hence these two are being compared with new device Mini bronchoalveolar Lavage  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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   3 days after the procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Helps in finding the antibiotics sensitivity early and there by reducing the resistance to antibiotics   3 days after the procedure  
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 .

 


 
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