Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

• Conditions: COPD Asthma; Pulmonary Fibrosis

• Registration Number: NCT03056066
• Lead Sponsor: Spircare Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-17
• Study Start: 2017-07-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-29
• Last Update Posted: 2018-05-01
• Primary Completion: 2018-11
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

"Meir" Medical Center; 🇮🇱 Kfar-Saba, Israel