Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
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ClinicalTrials.gov Identifier: NCT03056066
Recruitment Status : Unknown
Verified April 2018 by Spircare Ltd.. Recruitment status was: Enrolling by invitation
The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.
The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device [ Time Frame: September 2017 ]
The primary outcome of the FRC and air way resistance of the Spircare device against the plethysmograph will be displayed as scatter plot. A linear regression and the R2 value will be display as well. The associated Bland-Altman plots comparing the FRC and airway resistance of the Spircare device to the plethysmograph with lines that represent width of 0.1 (±1.96*SD).
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Phase I Health subjects without respiratory system disease.
Phase II Subjects which are referred to a Pulmonary Functional Testing in the Meir pulmonary unit.
Signed Informed consent.
Subject is cooperative and capable of following instructions.
Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
Phase II: Chronic pulmonary patients with lung volume disorders:
Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders.
Subjects unable or unwilling to give informed consent.
Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia).
History suggesting upper respiratory infection during the four weeks prior to testing
Physical activity during 1 hour prior to the Study.