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OpenTrials
Completed

NCT Number: NCT04919200

Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease

Whole-body plethysmography (WBP) is the gold standard for measuring lung volume, but its clinical application is limited because it requires expensive equipment and is complicated to use. Studies have shown that the single-breath helium dilution (SBHD) method, which is commonly used in clinical practice, significantly underestimates lung volume in patients with obstructive lung disease (OLD). Therefore, by comparing the differences in lung volume measured by the SBHD method and WBP in patients with different severities of obstructive lung disease, we aim to establish a correction equation for the SBHD method to determine the total lung volume in obstructive lung disease patients.

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Key information

Conditions

Obstructive Lung Disease Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) age 18-80 years and (2) in line with the ATS/ERS definition of obstructive lung disease.

Exclusion criteria

(1) contraindications for spirometry, pulmonary diffusion function test, and WBP and (2) history of lung surgery and recent history of chest trauma.

Treatment and study plan

the single-breath helium dilution method and Whole-body plethysmography

Diagnostic Test

The patients with obstructive lung disease simultaneously subjected to the single-breath helium dilution method and Whole-body plethysmography tests.

Primary outcomes

  1. Establishment of the TLC-SBHD correction equation

    Time frame: 2 year

    TLC-adjusted SBHD (L) = -0.669 + 0.756 × TLC-SBHD (L) - 0.047 × FEV1/FVC + 0.039 × height (cm) - 0.009 × weight (kg) (r2 = 0.753 and adjusted r2 = 0.751)

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Measurement of the Total Lung Volume Using Optimized Single-breath Helium Dilution Method in Patients With Obstructive Lung Disease

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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