Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
NCT ID: NCT01952431
Last Updated: 2014-11-11
Study Results
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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COMPLETED
NA
100 participants
INTERVENTIONAL
2013-04-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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PulmOne MiniBox PFT
Total Lung Capacity (TLC) testing with PulmOne MiniBoxPFT
Total Lung Capacity (TLC) testing
Comparison of TLC results
ZAN500
Total Lung Capacity (TLC) testing with ZAN500.
Total Lung Capacity (TLC) testing
Comparison of TLC results
Interventions
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Total Lung Capacity (TLC) testing
Comparison of TLC results
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is cooperative and capable of following instructions.
3. Healthy subjects:
1. Never smokers.
2. No known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
3. BMI \< 35.
4. No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea, chronic cough, wheezing or phlegm).
5. No history suggesting upper respiratory infection during the three weeks prior to testing.
4. Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.
Exclusion Criteria
2. Subjects unable or unwilling to give informed consent.
3. Subjects who have performed any significant physical activity during 1 hour prior to the Study.
4. Patients with a tracheostomy.
5. Pregnant women.
18 Years
ALL
Yes
Sponsors
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PulmOne Advanced Medical Devices, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Mordechai Yigla, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam University Medical Center
Locations
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Rambam University Medical Center
Haifa, , Israel
Countries
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Other Identifiers
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PulmOne-1.0
Identifier Type: -
Identifier Source: org_study_id