BronchoscopyNCT01853904
Utility of Syringe Based Suction Versus Channel Suction in Bronchoalveolar Lavage
A study testing Bronchoscopy/ BAL with Channel Suction and Bronchoscopy/BAL with Syringe Suction in people with Bronchoscopy, run by University of Oklahoma at 1 site in United States.
Trial summary
Bronchoalveolar lavage (BAL) is a common technique among pulmonologists. Its goal is to collect cells from alveolar units. This is done by wedging a flexible bronchoscope in a bronchus, instilling saline, and removing the saline via suction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- Bronchoscopy/ BAL with Channel Suction and Bronchoscopy/BAL with Syringe Suction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bronchoscopy scheduled
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Bronchoalveolar lavage (BAL) is a common technique among pulmonologists. Its goal is to collect cells from alveolar units. This is done by wedging a flexible bronchoscope in a bronchus, instilling saline, and removing the saline via suction. Two techniques are currently used for suctioning: syringe based and channel suction.
The investigators concern is that channel suction creates too much force and there is collapsing of the airways which results in decreased fluid removal as well as cell sampling. The investigators propose that syringe based suctioning will not only return more of the instilled fluid but also more cells from the alveoli.
Read the detailed description
The pulmonary segment with the most disease on imaging will be the segment sampled. The scope will be wedged in the airway leading to that segment and 100mL of saline will be instilled into the selected segment and collected via the syringe based or channel based suction. Prior to unwedging, another 100mL of saline will be instilled into the same segment and will be collected using the alternative method. There will not be randomization, but the investigators will alternate which method is used first to eliminate confounding variables. All patients will receive both modalities of suctioning. The wall suction used for the channel suction will be set at 80 mm Hg. Syringe based suctioning will be performed with 20mL syringe. Total amount of fluid collected will be recorded and samples will be sent for cell count and differential as well as Gram stain and culture. Results of the two techniques will then be compared to determine which is the superior suctioning modality for BAL.
- Conditions
- Bronchoscopy
- Being tested
- Bronchoscopy/ BAL with Channel Suction, Bronchoscopy/BAL with Syringe Suction
- Keywords
- Bronchoscopy, BAL, Suction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy/ BAL with Channel SuctionProcedure or surgery
The wall suction used for the channel suction will be set at 80 mm Hg. This arm is for patients who will receive channel suction first to obtain the specimen then syringe suction to obtain the specimen.
Bronchoscopy/BAL with Syringe SuctionProcedure or surgery
Syringe based suctioning will be performed with 20mL syringe.
| Study group | Role | What they receive |
|---|---|---|
| Channel Suction first | Other | This arm is for patients who will receive channel suction first to obtain the specimen then syringe suction to obtain the specimen. Receives: Procedure: Bronchoscopy/ BAL with Channel Suction; Procedure: Bronchoscopy/BAL with Syringe Suction |
| Syringe Suction first | Other | This arm is for patients who will receive syringe suction first to obtain the specimen then channel suction to obtain the specimen. Receives: Procedure: Bronchoscopy/ BAL with Channel Suction; Procedure: Bronchoscopy/BAL with Syringe Suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Syringe Suction versus Channel Suction to retrieve volume
Measured: 24 hours
Secondary outcomes (1)
Efficacy of Syringe suction versus Channel suction to retrieve alveolar cells
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Brown, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853904
- Sponsor's protocol ID
- 2296
- Status last verified
- Jan 2014
- First submitted
- 5 Apr 2013
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Syringe Based Suction Versus Channel Suction in Bronchoalveolar Lavage
- ClinicalTrials.gov ID
- NCT01853904
- Acronym / sponsor ID
- 2296
- Conditions
- Bronchoscopy
- Keywords
- Bronchoscopy, BAL, Suction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 May 2013 (estimated)
- 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) is a common technique among pulmonologists. Its goal is to collect cells from alveolar units. This is done by wedging a flexible bronchoscope in a bronchus, instilling saline, and removing the saline via suction. Two techniques are currently used for suctioning: syringe based and channel suction.
The investigators concern is that channel suction creates too much force and there is collapsing of the airways which results in decreased fluid removal as well as cell sampling. The investigators propose that syringe based suctioning will not only return more of the instilled fluid but also more cells from the alveoli.
Detailed description
The pulmonary segment with the most disease on imaging will be the segment sampled. The scope will be wedged in the airway leading to that segment and 100mL of saline will be instilled into the selected segment and collected via the syringe based or channel based suction. Prior to unwedging, another 100mL of saline will be instilled into the same segment and will be collected using the alternative method. There will not be randomization, but the investigators will alternate which method is used first to eliminate confounding variables. All patients will receive both modalities of suctioning. The wall suction used for the channel suction will be set at 80 mm Hg. Syringe based suctioning will be performed with 20mL syringe. Total amount of fluid collected will be recorded and samples will be sent for cell count and differential as well as Gram stain and culture. Results of the two techniques will then be compared to determine which is the superior suctioning modality for BAL.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Channel Suction first | Other | Procedure: Bronchoscopy/ BAL with Channel Suction, Procedure: Bronchoscopy/BAL with Syringe SuctionThis arm is for patients who will receive channel suction first to obtain the specimen then syringe suction to obtain the specimen. |
| Syringe Suction first | Other | Procedure: Bronchoscopy/ BAL with Channel Suction, Procedure: Bronchoscopy/BAL with Syringe SuctionThis arm is for patients who will receive syringe suction first to obtain the specimen then channel suction to obtain the specimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bronchoscopy scheduled
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Bronchoscopy/ BAL with Channel SuctionThe wall suction used for the channel suction will be set at 80 mm Hg. This arm is for patients who will receive channel suction first to obtain the specimen then syringe suction to obtain the specimen. | Procedure or surgery | Channel Suction first, Syringe Suction first |
| Bronchoscopy/BAL with Syringe SuctionSyringe based suctioning will be performed with 20mL syringe. | Procedure or surgery | Channel Suction first, Syringe Suction first |
Primary outcome
Efficacy of Syringe Suction versus Channel Suction to retrieve volume
Time frame: 24 hours
1 secondary outcome
Efficacy of Syringe suction versus Channel suction to retrieve alveolar cells
Time frame: 24 hours
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 7 Jan 2014.
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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.
Brent Brown, MD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy/ BAL with Channel Suction and Bronchoscopy/BAL with Syringe Suction in people with Bronchoscopy, run by University of Oklahoma at 1 site in United States.
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 1 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 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Efficacy of Syringe Suction versus Channel Suction to retrieve volume (time frame: 24 hours). 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 7 Jan 2014.