Interstitial Lung DiseaseNCT03388580
Predictors for Bronchoalveolar Lavage (BAL) Recovery Rate Derived From Quantified Computed Tomography (qCT)
An observational study of Interstitial Lung Disease and Pneumonia, run by Universitätsmedizin Mannheim.
Trial summary
Bronchoalveolar lavage (BAL) is an important diagnostic method. The percentage of fluid extracted after instillation (recovery rate) is crucial for following diagnostic tests. The investigators aimed to compare novel quantified airway parameters from pre-interventional lung computed tomography (CT) with recovery rates… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Pneumonia, Malignant Neoplasm
- What is being tested?
- bronchoalveolar lavage (BAL)
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Sep 2017
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective BAL with clinical indication.
Who may be able to join
- retrospective analysis of all patients undergoing BAL and complete documentation
Who cannot join
- incomplete documentation
About this study
Official title: Predictors for Bronchoalveolar Lavage Recovery Rate Derived From Quantified Computed Tomography
Bronchoalveolar lavage (BAL) is an important diagnostic method. The percentage of fluid extracted after instillation (recovery rate) is crucial for following diagnostic tests. The investigators aimed to compare novel quantified airway parameters from pre-interventional lung computed tomography (CT) with recovery rates to find possible predictive markers.
- Conditions
- Interstitial Lung Disease, Pneumonia, Malignant Neoplasm
- Being tested
- bronchoalveolar lavage (BAL)
- Medical subject headings
- Lung Diseases, Interstitial, Pneumonia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoalveolar lavage (BAL)Procedure or surgery
clinically indicated, elective BAL
| Study group | Role | What they receive |
|---|---|---|
| BAL | patients undergoing elective bronchoalveolar lavage Receives: Procedure: bronchoalveolar lavage (BAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery rate
volume of recovered volume
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study startJan 2017
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388580
- Sponsor's protocol ID
- qCT - BAL
- Status last verified
- Jan 2018
- First submitted
- 24 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Bronchoalveolar Lavage Recovery Rate Derived From Quantified Computed Tomography
- ClinicalTrials.gov ID
- NCT03388580
- Acronym / sponsor ID
- qCT - BAL
- Conditions
- Interstitial Lung Disease, Pneumonia, Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 3 Jan 2018 (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) is an important diagnostic method. The percentage of fluid extracted after instillation (recovery rate) is crucial for following diagnostic tests. The investigators aimed to compare novel quantified airway parameters from pre-interventional lung computed tomography (CT) with recovery rates to find possible predictive markers.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAL | – | Procedure: bronchoalveolar lavage (BAL)patients undergoing elective bronchoalveolar lavage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective BAL with clinical indication.
Key inclusion criteria (1 listed)
- retrospective analysis of all patients undergoing BAL and complete documentation
Key exclusion criteria (1 listed)
- incomplete documentation
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 (BAL)clinically indicated, elective BAL | Procedure or surgery | BAL |
Primary outcome
recovery rate
Time frame: 30 minutes
volume of recovered volume
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 4 Jan 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Pneumonia, run by Universitätsmedizin Mannheim.
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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
recovery rate (time frame: 30 minutes). 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 4 Jan 2018.