Bronchoalveolar LavaageBAL-3TNCT05425875
Comparison of Procedural Yield of Bronchoalveolar Lavage Using Three Different Techniques in Subjects Undergoing Flexible Bronchoscopy
A study testing Bronchoalveolar lavage using wall mount suction, Bronchoalveolar lavage using manual suction and Bronchoalveolar lavage using manual suction with rubber tubing in people with Bronchoalveolar Lavaage and Diffuse Lung Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bronchoalveolar Lavaage, Diffuse Lung Disease
- What is being tested?
- Bronchoalveolar lavage using wall mount suction, Bronchoalveolar lavage using manual suction and Bronchoalveolar lavage using manual suction with rubber tubing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 942 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jun 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing BAL procedure for various indications using flexible bronchoscopy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
India2 sites
Bronchoscopy suite, PGIMER
Chandigarh, 160012
Bronchoscopy suite
Chandigarh, 160012
About this study
Official title: A Randomized Controlled Trial to Compare Procedural Yield of Bronchoalveolar Lavage Using Three Different Techniques in Subjects Undergoing Flexible Bronchoscopy
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
Read the detailed description
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.
A prospective clinical study of 66 patients by Naghmeh Radhakrishna[9], comparing techniques for optimal BAL performance used 100ml NS (with 4 aliquots) resulted in no significant difference between both techniques.
Another study to compare two aspiration techniques of BAL in children was conducted by Christian Rosas-Salazar[10] on approximately 540 procedures. Their results suggested that handheld syringe suction provide higher % of fluid return when compared to continuous wall suction.
K.S Woods[11], did a randomized, blinded prospective clinical trial on 18 dogs comparing manual and suction pump aspiration techniques for BAL. 35 ml syringe was used to instill 2ml/kg volumes per site for manual aspiration. Negative pressure of maximum 50mmHg was applied for SPA. Thus, concluded the study showing higher % of BALF return by SPA than manual suction with or without tubing. There was no significant difference in diagnostic yield.
One more multicenter randomized study by Antoni Rosell[12] was conducted to recover BAL fluid comparing only syringe and syringe with attached plastic tube (40cm), for more fluid return. Thus, it resulted in 8% more fluid recovery, more yield and less complications with syringe with tubing suction technique.
To the best of author's knowledge no previous study has compared the three methods of obtaining the BAL in the same cohort of subjects. The investigators 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.
Study question: Is the procedural yield of BAL different between manual suction using rubber tubing compared to manual suction without rubber tubing or wall suction?
- Conditions
- Bronchoalveolar Lavaage, Diffuse Lung Disease
- Being tested
- Bronchoalveolar lavage using wall mount suction, Bronchoalveolar lavage using manual suction, Bronchoalveolar lavage using manual suction with rubber tubing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar lavage using wall mount suctionProcedure or surgery
BAL will be performed using wall mount suction with a pressure <100 mmHg
Bronchoalveolar lavage using manual suctionProcedure or surgery
A 50-mL syringe will be used to apply suction through the working channel of a bronchoscope
Bronchoalveolar lavage using manual suction with rubber tubingProcedure or surgery
A 50-mL syringe with an attached rubber tubing will be used to apply suction through the working channel of a bronchoscope
| Study group | Role | What they receive |
|---|---|---|
| Manual suction | Experimental | A 50-mL syringe will be used to apply the suction. Receives: Procedure: Bronchoalveolar lavage using manual suction |
| Manual suction with tubing | Experimental | A 50-mL syringe with a 15-cm rubber tubing. Receives: Procedure: Bronchoalveolar lavage using manual suction with rubber tubing |
| Wall mount suction | Active comparator | A negative pressure of <100 mmHg will be applied using continuous wall suction. Receives: Procedure: Bronchoalveolar lavage using wall mount suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare proportional procedures in which we obtain optimal yield
optimal yield will be defined if there is at least 30% return of volume instilled and adequate sample (<5% bronchial cells)
Measured: 1 hour (during bronchsocopy)
Secondary outcomes (3)
Diagnostic yield of BAL
Proportion of BAL in each arm that provide a specific diagnosis
Measured: 1 month
Percentage and volume of BAL fluid
Percentage of instilled volume of saline for performing BAL that returns while doing BAL and the exact volume of BAL
Measured: 1 hour (during bronchsocopy)
Proportion of subjects experiencing complications in each arm
Complications will include hypoxemia, fever, escalation of care (need for hospitalization, icu admission or airway intubation), airway bleeding, death, and others
Measured: 1 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jun 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchoalveolar LavaageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arm parallel group study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 942 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425875
- Sponsor's protocol ID
- INT/IEC/2021/SPI-1048
- Acronym
- BAL-3T
- Status last verified
- Aug 2023
- First submitted
- 10 Jun 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare Procedural Yield of Bronchoalveolar Lavage Using Three Different Techniques in Subjects Undergoing Flexible Bronchoscopy
- ClinicalTrials.gov ID
- NCT05425875
- Acronym / sponsor ID
- BAL-3T / INT/IEC/2021/SPI-1048
- Conditions
- Bronchoalveolar Lavaage, Diffuse Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 942 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
A prospective clinical study of 66 patients by Naghmeh Radhakrishna[9], comparing techniques for optimal BAL performance used 100ml NS (with 4 aliquots) resulted in no significant difference between both techniques.
Another study to compare two aspiration techniques of BAL in children was conducted by Christian Rosas-Salazar[10] on approximately 540 procedures. Their results suggested that handheld syringe suction provide higher % of fluid return when compared to continuous wall suction.
K.S Woods[11], did a randomized, blinded prospective clinical trial on 18 dogs comparing manual and suction pump aspiration techniques for BAL. 35 ml syringe was used to instill 2ml/kg volumes per site for manual aspiration. Negative pressure of maximum 50mmHg was applied for SPA. Thus, concluded the study showing higher % of BALF return by SPA than manual suction with or without tubing. There was no significant difference in diagnostic yield.
One more multicenter randomized study by Antoni Rosell[12] was conducted to recover BAL fluid comparing only syringe and syringe with attached plastic tube (40cm), for more fluid return. Thus, it resulted in 8% more fluid recovery, more yield and less complications with syringe with tubing suction technique.
To the best of author's knowledge no previous study has compared the three methods of obtaining the BAL in the same cohort of subjects. The investigators 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.
Study question: Is the procedural yield of BAL different between manual suction using rubber tubing compared to manual suction without rubber tubing or wall suction?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Three arm parallel group study
| Arm | Type | Receives |
|---|---|---|
| Manual suction | Experimental | Procedure: Bronchoalveolar lavage using manual suctionA 50-mL syringe will be used to apply the suction. |
| Manual suction with tubing | Experimental | Procedure: Bronchoalveolar lavage using manual suction with rubber tubingA 50-mL syringe with a 15-cm rubber tubing. |
| Wall mount suction | Active comparator | Procedure: Bronchoalveolar lavage using wall mount suctionA negative pressure of <100 mmHg will be applied using continuous wall suction. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing BAL procedure for various indications using flexible bronchoscopy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoalveolar lavage using wall mount suctionBAL will be performed using wall mount suction with a pressure <100 mmHg | Procedure or surgery | Wall mount suction |
| Bronchoalveolar lavage using manual suctionA 50-mL syringe will be used to apply suction through the working channel of a bronchoscope | Procedure or surgery | Manual suction |
| Bronchoalveolar lavage using manual suction with rubber tubingA 50-mL syringe with an attached rubber tubing will be used to apply suction through the working channel of a bronchoscope | Procedure or surgery | Manual suction with tubing |
Primary outcome
To compare proportional procedures in which we obtain optimal yield
Time frame: 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)
3 secondary outcomes
Diagnostic yield of BAL
Time frame: 1 month
Percentage and volume of BAL fluid
Time frame: 1 hour (during bronchsocopy)
Proportion of subjects experiencing complications in each arm
Time frame: 1 month after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Undecided. Data sharing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoalveolar lavage using wall mount suction, Bronchoalveolar lavage using manual suction and Bronchoalveolar lavage using manual suction with rubber tubing in people with Bronchoalveolar Lavaage and Diffuse Lung Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare proportional procedures in which we obtain optimal yield (time frame: 1 hour (during bronchsocopy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.