NCT00001464

Completed

Effect of High Levels of Oxygen and Smoking on the Lungs in ...

National Heart, Lung, and Blood Institute (NHLBI)Source

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Other study identifiers

Sponsor study identifier

950167

Secondary identifiers

95-H-0167

Study Type

observational

Actual enrollment (reported)

77

Locations

1 country

Sites

1

Timeline

Study Start

August 22, 1995

Actual (reported)

Primary Completion

July 10, 2007

Actual (reported)

Study Completion

July 10, 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 77 participants
Study completion date: July 10, 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 22, 1995
Actual (reported)
First Submitted
November 3, 1999
Actual (reported)
First Posted
November 4, 1999
Actual (reported)
Primary Completion
July 10, 2007
Actual (reported)
Study Completion
July 10, 2007
Actual (reported)

Last Updated: August 27, 2021
Status Verified: August 2021
Last Update Submitted: August 26, 2021

Conditions

Healthy Volunteers

Keywords

OxygenBronchoalveolar LavageDNA RepairCarbonyl GroupsSerumHuman 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

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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;

Sponsors & Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

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: 6247652BACKGROUND
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: 8226538BACKGROUND

Study Officials

Joel Moss, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
PRINCIPAL INVESTIGATOR

Enrollment

77 participants (actual enrollment reported by the registry).

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

Actual (reported)

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NCT02860975

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Not ApplicableTerminated

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.

Contact the study team to confirm eligibility.

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: 6888481BACKGROUND

Primary Completion

July 10, 2007

Actual (reported)

Study Completion

July 10, 2007

Actual (reported)

Last Updated

August 27, 2021

Record last verified: 2021-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00001464
Data provider: ClinicalTrials.gov
Source updated: 2021-08-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:49 UTC

Locations

US(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Group 1

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Group 1

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations