Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease

Obstructive Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919200
• Other study ID #: 2021-0547
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Lung Disease

Intervention

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

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of the TLC-SBHD correction equation	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)	2 year