| 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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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, |
|
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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 |
|
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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
|
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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 . |