Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide

COPD Clinical Trial

— DLCO  

Official title:

Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide in Normal Subjects and Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235297
• Other study ID #: DLCO
• Status: Completed
• Start date: August 10, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2020
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to further understand the effects of altitude on the physiology of gas exchange in the pulmonary microcirculation in normal subjects and in people with chronic obstructive pulmonary disease (COPD) measured as the single-breath diffusing capacity for carbon monoxide (DLCOsb). The study will determine a mathematical formula to allow for altitude corrections in both study populations to be used clinically in pulmonary labs.

Description:

The DLCOsb is one of the most common and widely tests clinically used across the world in pulmonary function laboratories to assess gas exchange from the lung to hemoglobin in the pulmonary circulation. This test is used in the differential diagnosis of respiratory related symptoms, to grade the degree of severity in lung disease, and to objectively monitor the progression of disease or the response to therapies. Therefore, it is important to have standard methods of performing and interpreting this test.This is a prospective study, collecting data from subjects at different simulated altitudes. The study hypothesis is that increasing altitude will increase the DLCOsb in a predictable manner that will allow for mathematical corrections to be applied for uniform interpretation in pulmonary labs at differing altitudes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 1, 2019
• Est. primary completion date: June 15, 2018
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ages 20- 80 years

• Subjects must be either healthy or have been diagnosed with COPD

Exclusion Criteria:

• Anemia (hemoglobin < 10.0 g/dL)

• Carboxyhemoglobin > 3%

• Active smoking

• Heart disease or heart failure

• Pulmonary hypertension

• COPD exacerbation

• Pneumothroax within 6 months

• Bullous emphysema on chest imaging (Chest X-ray or CT)

• Supplemental oxygen use

• Diabetes mellitus

• Alcohol dependence

• Non-English speaking

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of altitude on measured diffusing capacity for carbon monoxide		3 weeks
Secondary	Comparison of a novel inert gas technique for measuring alveolar volume with body plethysmography		4 months