Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

Pulmonary Fibrosis Clinical Trial

Official title:

Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03056066
• Other study ID #: DA-1
• Status: Enrolling by invitation
• Start date: July 31, 2017
• Est. completion date: January 2019

Study information

• Verified date: April 2018
• Source: Spircare Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: January 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD Asthma
• Pulmonary Fibrosis

Intervention

Device:
• Plethysmograph
A full Body Plethysmography examination

Locations

Country	Name	City	State
Israel	"Meir" Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Spircare Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device	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).	September 2017