Exploratory Study of Potential Pulmonary Aspiration Markers From Bronchoalveolar Lavage Fluid

NCT00915941 | Completed DMC

• 1 other identifier: 07-000550
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchoscopy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Undergoing bronchoscopy for clinical reasons
• years of age or older
• Ordering clinician and bronchoscopist is consenting

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

BALF specimens will be collected by the MCF Biospecimen Facility at the time of the bronchoscopy. A minimum of 5 mL will be collected. Specimen processing will include centrifugation to separate the cell pellet from the supernatant. The supernatant will be stored in 2 mL cryovials, and stored at -70°C until time of testing for the pepsin-ELISA. Storage will allow retesting at another date if the assay is modified or if another substance of interest arises in the course of the study that requires re-testing of the specimens. The clinical sample will also be tested through the Mayo Clinic medical laboratory for bilirubin, pepsinogen, amylase, and lipase.

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 11, 2011

Record last verified: 2011-11

Locations

US (1)