Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)

Study Overview
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Brief Summary
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A comparative study to test the efficacy of a novel device - the MiniBoxPFT, in measuring TLC (total lung capacity) compared to TLC measured by standard body plethysmography using the ZAN 500. The study will be conducted as a prospective two-arm, open, randomized comparative study.

Detailed Description
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This study is a prospective, multi-centered, randomized, comparative study designed to demonstrate substantially equivalence performance of the proposed device, the PulmOne MiniBoxPFT, to its predicate device, the ZAN500, for the measurement of total lung capacity (TLC).

Official Title
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Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)

Conditions
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TLC in Patients With and Without Respiratory System Disease

Intervention / Treatment
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* Device: Total Lung Capacity (TLC) testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years of age. Subject is cooperative and capable of following instructions. Healthy subjects: Never smokers. No known history of respiratory, cardiovascular, hepatic, renal or metabolic disease. BMI < 35. No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea, chronic cough, wheezing or phlegm). No history suggesting upper respiratory infection during the three weeks prior to testing. Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality. Exclusion Criteria: Subjects who are unable to satisfactorily perform routine, full lung function testing(due to non-compliance or claustrophobia). Subjects unable or unwilling to give informed consent. Subjects who have performed any significant physical activity during 1 hour prior to the Study. Patients with a tracheostomy. Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PulmOne MiniBox PFT<br>Total Lung Capacity (TLC) testing with PulmOne MiniBoxPFT | Device: Total Lung Capacity (TLC) testing<br>* Comparison of TLC results<br>* Other names: TLC;|
| Active Comparator: ZAN500<br>Total Lung Capacity (TLC) testing with ZAN500. | Device: Total Lung Capacity (TLC) testing<br>* Comparison of TLC results<br>* Other names: TLC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Lung Capacity (TCL) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Lung Capacity