Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Fibrosis; COPD Asthma
• Intervention / Treatment: Device: Plethysmograph

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Israel
  • Kfar-Saba, Israel, 4428164
    • "Meir" Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Phase I Health subjects without respiratory system disease.

Phase II Subjects which are referred to a Pulmonary Functional Testing in the Meir pulmonary unit.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Spircare Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis
• Other Study ID Numbers: DA-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No