Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease

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

Study Overview

• Status: Completed
• Conditions: Obstructive Lung Disease
• Intervention / Treatment: Diagnostic test: the single-breath helium dilution method and Whole-body plethysmography

• Study Type: Observational
• Enrollment (Actual): 628

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

628 patients with obstructive lung disease simultaneously subjected to the single-breath helium dilution method and Whole-body plethysmography tests in Second Affiliated Hospital of Zhejiang University School of Medicine were continuously enrolled from January 2018 to December 2020

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
modeling group; Of these 628 individuals, we set 407 patients enrolled from January 2018 to November 2019 as the modeling group	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.
verification cohort; 221 patients enrolled from December 2019-December 2020 served as a prospective verification cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: obstructive lung disease; total lung capacity; the single-breath helium dilution; Whole-body plethysmography; correction equation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: 2021-0547

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No