Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease

Zhejiang University

Status: Completed

Conditions: Obstructive Lung Disease

Treatments: Diagnostic Test: the single-breath helium dilution method and Whole-body plethysmography

Study type: Observational

Funder types: Other

Identifiers

NCT04919200

2021-0547

Details and patient eligibility

About

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.

Enrollment: 628 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

628 participants in 2 patient groups

modeling group

Description:

Of these 628 individuals, we set 407 patients enrolled from January 2018 to November 2019 as the modeling group

Treatment:

Diagnostic Test: the single-breath helium dilution method and Whole-body plethysmography

verification cohort

Description:

221 patients enrolled from December 2019-December 2020 served as a prospective verification cohort

Treatment:

Diagnostic Test: the single-breath helium dilution method and Whole-body plethysmography