Effect of High Levels of Oxygen and Smoking on the Lungs in Human Volunteers

NCT00001464 | Completed

• 2 other identifiers: 95016795-H-0167
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with lung disease experiencing difficulty breathing can be treated with oxygen therapy. This involves the delivery of "extra" oxygen by a face-mask or through small tubes placed in the nose called nasal prongs. This extra oxygen can have concentrations as high as 100% pure oxygen. The concentration of oxygen in normal air is only 21%. The high concentration of oxygen can help to provide enough oxygen for all of the organs in the body. Unfortunately, breathing 100% oxygen for long periods of time can cause changes in the lungs, which are potentially harmful. Researchers believe that by lowering the concentration of oxygen therapy to 40% patients can receive it for longer periods of time without the risk of side effects. This study is designed to evaluate the effects of oxygen therapy at 100% and 40% for 12 18 hours on the lungs of normal volunteers. Results of this study will help to determine if levels of oxygen therapy currently accepted as being "safe" may actually be damaging to the lungs.

Conditions

Healthy Volunteers

Keywords

Oxygen; Bronchoalveolar Lavage; DNA Repair; Carbonyl Groups; Serum; Human Volunteers

Outcome Measures

Primary Outcomes (1)

• To determine whether hyperoxia of relatively limited duration (up to l8 hrs) is associated with oxidation of proteins and nucleic acids in lung cells.

  To determine whether hyperoxia of relatively limited duration (up to l8 hrs) is associated with oxidation of proteins and nucleic acids in lung cells.

  1 week

Study Arms (1)

Group 1

Smokers exposed to oxygen

Eligibility Criteria

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

Study Population

Individuals exposed to oxygen or who are smokers.@@@

You may qualify if:

• History - good overall health without history of recent (within 3 months) acute disease;
• Physical examination within normal limits;
• Laboratory evaluation; including complete blood count (CBC), serum electrolyte determinations, clotting times, chest x-ray, pulmonary function testing, and an electrocardiogram (EKG) - within normal limits;
• Non-smokers defined as having never smoked or not smoked in the past 2 years;
• Smokers defined as moderate (1 pack per day for 3+ years) or heavy (1-2 packs for 10+ years);
• Subjects must be willing to make the time commitment necessary for the study.

You may not qualify if:

• Any study subject who does not fulfill the criteria for eligibility.
• Individuals with a history of allergy or adverse reactions to atropine or any local anesthetic;
• Individuals testing positive for the human immunodeficiency virus or hepatitis virus;
• Individuals on chronic medications or currently receiving medications;
• Pregnant or lactating individuals, since the effects of hyperoxia on the fetus are unclear.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Deneke SM, Fanburg BL. Normobaric oxygen toxicity of the lung. N Engl J Med. 1980 Jul 10;303(2):76-86. doi: 10.1056/NEJM198007103030204. No abstract available.

  PMID: 6247652 BACKGROUND

• Erzurum SC, Danel C, Gillissen A, Chu CS, Trapnell BC, Crystal RG. In vivo antioxidant gene expression in human airway epithelium of normal individuals exposed to 100% O2. J Appl Physiol (1985). 1993 Sep;75(3):1256-62. doi: 10.1152/jappl.1993.75.3.1256.

  PMID: 8226538 BACKGROUND

• Davis WB, Rennard SI, Bitterman PB, Crystal RG. Pulmonary oxygen toxicity. Early reversible changes in human alveolar structures induced by hyperoxia. N Engl J Med. 1983 Oct 13;309(15):878-83. doi: 10.1056/NEJM198310133091502.

  PMID: 6888481 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Joel Moss, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: August 22, 1995
• Primary Completion: July 10, 2007
• Study Completion: July 10, 2007
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

US (1)