Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

NCT03056066 | Unknown

• 1 other identifier: DA-1
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Asthma; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Plethysmograph DEVICE

A full Body Plethysmography examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Signed Informed consent.
• Age≥18 year.
• Subject is cooperative and capable of following instructions.
• Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Spircare Ltd.: lead

Study Sites (1)

"Meir" Medical Center

Kfar Saba, 4428164, Israel

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 17, 2017
• Study Start: July 31, 2017
• Primary Completion: November 1, 2018
• Study Completion: January 1, 2019
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

IL (1)