Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03056066

Enrollment

Registered

2017-02-17

Start date

2017-07-31

Completion date

2019-01-31

Last updated

2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Asthma, Pulmonary Fibrosis

Brief summary

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.

Interventions

DEVICEPlethysmograph

A full Body Plethysmography examination

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Signed Informed consent. 2. Age≥18 year. 3. Subject is cooperative and capable of following instructions. 4. Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease. 5. Phase II: Chronic pulmonary patients with lung volume disorders: * COPD * Asthma * Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders.

Exclusion criteria

1. Subjects unable or unwilling to give informed consent. 2. Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia). 3. History suggesting upper respiratory infection during the four weeks prior to testing 4. Physical activity during 1 hour prior to the Study. 5. Patients with a tracheostomy. 6. Pregnant women.

Design outcomes

Primary

Measure	Time frame	Description
The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device	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).

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026