Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease

NCT ID: NCT04919200

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

628 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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modeling group

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

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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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

Site Status

Countries

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China

Other Identifiers

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2021-0547

Identifier Type: -

Identifier Source: org_study_id

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