Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

Spircare

Status: Unknown

Conditions: Pulmonary Fibrosis; COPD Asthma

Treatments: Device: Plethysmograph

Study type: Observational

Funder types: Industry

Identifiers

NCT03056066

DA-1

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.