Exploratory Study of Potential Pulmonary Aspiration Markers From Bronchoalveolar Lavage Fluid

Bronchoscopy Clinical Trial

— Pepsin  

Official title:

Exploratory Study of Potential Pulmonary Aspiration Markers From Bronchoalveolar Lavage Fluid"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915941
• Other study ID #: 07-000550
• Status: Completed
• Phase: N/A
• First received: June 5, 2009
• Last updated: November 10, 2011
• Start date: January 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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:

1. Confirm pepsin can be detected and quantitated in BALF obtained during a routine bronchoscopy.

2. Identify specific pulmonary pathologies that are more often associated with increased pepsin BAL levels.

3. Identify a normal range of pepsin in BALF in control normals.

4. Identify any correlation of pepsin BAL levels with reflux, swallow, or respiratory symptoms (standardized questionnaires).

5. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Undergoing bronchoscopy for clinical reasons

2. 21 years of age or older

3. Ordering clinician and bronchoscopist is consenting

Exclusion Criteria:

1. Emergent bronchoscopies

2. Bronchoscopies performed in the operating room

3. Pre-procedural oxygen requirement > 2 LPM for those who do not have a bronchoalveolar lavage ordered by the clinician as part of the bronchoscopy

4. Pre-procedural bronchospasm for those who do not have a bronchoalveolar lavage ordered by the clinician as part of the bronchoscopy

5. BAL is not requested for clinical reasons in a hospitalized or a mechanically ventilated patient

6. 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

7. 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchoscopy

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,