Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease

NCT04919200 | Completed

• 1 other identifier: 2021-0547
• Study Type: observational
• Target: 628
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Lung Disease

Keywords

obstructive lung disease; total lung capacity; the single-breath helium dilution; Whole-body plethysmography; correction equation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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.

modeling group; verification cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Interventions

Plethysmography, Whole Body

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Plethysmography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

CN (1)