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出境医 / 临床实验 / Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease
Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Obstructive Lung Disease | Diagnostic Test: the single-breath helium dilution method and Whole-body plethysmography |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 628 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Measurement of the Total Lung Volume Using Optimized Single-breath Helium Dilution Method in Patients With Obstructive Lung Disease |
| Actual Study Start Date : | January 1, 2018 |
| Actual Primary Completion Date : | December 31, 2020 |
| Actual Study Completion Date : | December 31, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
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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
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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.
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verification cohort
221 patients enrolled from December 2019-December 2020 served as a prospective verification cohort
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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.
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Outcome Measures
Primary Outcome Measures :
- Establishment of the TLC-SBHD correction equation [ Time Frame: 2 year ]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)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
Criteria
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.
Contacts and Locations
Locations
| China, Zhejiang | |
| 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 | |
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 3, 2021 | ||||
| First Posted Date | June 9, 2021 | ||||
| Last Update Posted Date | June 9, 2021 | ||||
| Actual Study Start Date | January 1, 2018 | ||||
| Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Establishment of the TLC-SBHD correction equation [ Time Frame: 2 year ] 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)
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease | ||||
| Official Title | Measurement of the Total Lung Volume Using Optimized Single-breath Helium Dilution Method in Patients With Obstructive Lung Disease | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition | 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.
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
628 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2020 | ||||
| Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
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. |
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04919200 | ||||
| Other Study ID Numbers | 2021-0547 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Study Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Verification Date | June 2021 | ||||