BronchoscopyPepsinNCT00915941
Exploratory Study of Potential Pulmonary Aspiration Markers From Bronchoalveolar Lavage Fluid
An observational study of Bronchoscopy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to learn if chemicals from the mouth or stomach can be found in the lungs. This may suggest a process called aspiration. This study may help us understand if aspiration plays a role in different lung diseases. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchoscopy
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2011
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects will be recruited from the Mayo Clinic Jacksonville site. As defined in the inclusion criteria, patients will only be identified once they are scheduled for a bronchoscopy for clinical indications. Only adult patients will be considered, and there will be no regard to gender or ethnicity in the screening or selection. The BAL procedure may or may not be requested by the referring clinician as part of the patient's bronchoscopy. In those subjects where the BAL is not requested for clinical indications, that means the BAL will be an additional procedure to be added to the patient's bronchoscopy for research purposes. Both patients in the inpatient and outpatient settings will be recruited, but emergent or operating room based bronchoscopies will be excluded. The specific inclusion and exclusion criteria are listed below.
Who may be able to join
- Undergoing bronchoscopy for clinical reasons
- 21 years of age or older
- Ordering clinician and bronchoscopist is consenting
Who cannot join
- Emergent bronchoscopies
- Bronchoscopies performed in the operating room
- Pre-procedural oxygen requirement > 2 LPM for those who do not have a bronchoalveolar lavage ordered by the clinician as part of the bronchoscopy
- Pre-procedural bronchospasm for those who do not have a bronchoalveolar lavage ordered by the clinician as part of the bronchoscopy
- BAL is not requested for clinical reasons in a hospitalized or a mechanically ventilated patient
- The study coordinator, investigator, clinician, or the bronchoscopist may at any time withdraw the patient with regards to any concerns on patient safety or if there is concerns on the patient's or patient's surrogate's ability to give an informed consent
- The clinician or the bronchoscopist may at any time withdraw the patient if by participating in the study, the bronchoalveolar fluid obtained is felt to be inadequate for clinical testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of Potential Pulmonary Aspiration Markers From Bronchoalveolar Lavage Fluid"
The purpose of this study is to learn if chemicals from the mouth or stomach can be found in the lungs. This may suggest a process called aspiration. This study may help us understand if aspiration plays a role in different lung diseases.
Read the detailed description
This study is a single center, prospective, observational study of determining pepsin levels in BALF samples obtained from consecutive bronchoscopies at the Mayo Clinic Jacksonville. It is inherently an exploratory pilot study to confirm whether pepsin in BAL can act as a marker of gastric to pulmonary aspiration and whether specific association to pulmonary pathologies can be identified.
As an overview, all patients who are undergoing a bronchoscopy for clinical indications will be screened for potential participation in the study by obtaining BALF samples during the procedure for laboratory analyses. The BALF will then be tested for pepsin at the Thoracic Diseases Research Unit (Mayo Clinic Rochester) using a commercially available ELISA kit, and the ancillary markers will be analyzed per the clinical laboratory. Internal controls will be defined as normals when subjects have no lung dysfunction, no respiratory symptoms, and no lung parenchymal infiltrates on chest radiographs.
The primary aims of this project parallels the short-term hypotheses stated above:
- Confirm pepsin can be detected and quantitated in BALF obtained during a routine bronchoscopy.
- Identify specific pulmonary pathologies that are more often associated with increased pepsin BAL levels.
- Identify a normal range of pepsin in BALF in control normals.
- Identify any correlation of pepsin BAL levels with reflux, swallow, or respiratory symptoms (standardized questionnaires).
- Identify any correlation between pepsin BAL levels and lung function test or radiographic abnormalities.
Secondary aims of the study will include exploratory analyses of lesser defined potential aspiration markers including bilirubin, lipase, amylase, and pepsinogen. Analyses of these markers will parallel the analyses performed for pepsin.
The focus of the study is to:
- definitively identify whether pulmonary aspiration is occurring;
- quantitate the burden of aspiration that is occurring (i.e., dose);
- localize from where aspiration is occurring (e.g., gastric, duodenal, biliary, oropharyngeal, nasal);
- identify what is specifically being aspirated (e.g., acid, exogenous oils, bacteria, gastric contents, bile, gastric enzymes, pancreatic enzymes).
- Conditions
- Bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionNov 2011
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 Mayo ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915941
- Sponsor's protocol ID
- 07-000550
- Acronym
- Pepsin
- Status last verified
- Nov 2011
- First submitted
- 5 Jun 2009
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Potential Pulmonary Aspiration Markers From Bronchoalveolar Lavage Fluid"
- ClinicalTrials.gov ID
- NCT00915941
- Acronym / sponsor ID
- Pepsin / 07-000550
- Conditions
- Bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Jun 2009 (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.
The purpose of this study is to learn if chemicals from the mouth or stomach can be found in the lungs. This may suggest a process called aspiration. This study may help us understand if aspiration plays a role in different lung diseases.
Detailed description
This study is a single center, prospective, observational study of determining pepsin levels in BALF samples obtained from consecutive bronchoscopies at the Mayo Clinic Jacksonville. It is inherently an exploratory pilot study to confirm whether pepsin in BAL can act as a marker of gastric to pulmonary aspiration and whether specific association to pulmonary pathologies can be identified.
As an overview, all patients who are undergoing a bronchoscopy for clinical indications will be screened for potential participation in the study by obtaining BALF samples during the procedure for laboratory analyses. The BALF will then be tested for pepsin at the Thoracic Diseases Research Unit (Mayo Clinic Rochester) using a commercially available ELISA kit, and the ancillary markers will be analyzed per the clinical laboratory. Internal controls will be defined as normals when subjects have no lung dysfunction, no respiratory symptoms, and no lung parenchymal infiltrates on chest radiographs.
The primary aims of this project parallels the short-term hypotheses stated above:
- Confirm pepsin can be detected and quantitated in BALF obtained during a routine bronchoscopy.
- Identify specific pulmonary pathologies that are more often associated with increased pepsin BAL levels.
- Identify a normal range of pepsin in BALF in control normals.
- Identify any correlation of pepsin BAL levels with reflux, swallow, or respiratory symptoms (standardized questionnaires).
- Identify any correlation between pepsin BAL levels and lung function test or radiographic abnormalities.
Secondary aims of the study will include exploratory analyses of lesser defined potential aspiration markers including bilirubin, lipase, amylase, and pepsinogen. Analyses of these markers will parallel the analyses performed for pepsin.
The focus of the study is to:
- definitively identify whether pulmonary aspiration is occurring;
- quantitate the burden of aspiration that is occurring (i.e., dose);
- localize from where aspiration is occurring (e.g., gastric, duodenal, biliary, oropharyngeal, nasal);
- identify what is specifically being aspirated (e.g., acid, exogenous oils, bacteria, gastric contents, bile, gastric enzymes, pancreatic enzymes).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects will be recruited from the Mayo Clinic Jacksonville site. As defined in the inclusion criteria, patients will only be identified once they are scheduled for a bronchoscopy for clinical indications. Only adult patients will be considered, and there will be no regard to gender or ethnicity in the screening or selection. The BAL procedure may or may not be requested by the referring clinician as part of the patient's bronchoscopy. In those subjects where the BAL is not requested for clinical indications, that means the BAL will be an additional procedure to be added to the patient's bronchoscopy for research purposes. Both patients in the inpatient and outpatient settings will be recruited, but emergent or operating room based bronchoscopies will be excluded. The specific inclusion and exclusion criteria are listed below.
Key inclusion criteria (3 listed)
- Undergoing bronchoscopy for clinical reasons
- 21 years of age or older
- Ordering clinician and bronchoscopist is consenting
Key exclusion criteria (7 listed)
- Emergent bronchoscopies
- Bronchoscopies performed in the operating room
- Pre-procedural oxygen requirement > 2 LPM for those who do not have a bronchoalveolar lavage ordered by the clinician as part of the bronchoscopy
- Pre-procedural bronchospasm for those who do not have a bronchoalveolar lavage ordered by the clinician as part of the bronchoscopy
- BAL is not requested for clinical reasons in a hospitalized or a mechanically ventilated patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 11 Nov 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoscopy, run by Mayo Clinic 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 3 inclusion and 7 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 11 Nov 2011. 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.
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 11 Nov 2011.