Personal Spirometer and Electrical Impedance Tomography: agreement with clinic attendance tests (SpiroEIT)

Not Applicable

Recruiting

• Conditions: Asthma; Chronic obstructive pulmonary disease (COPD); Cystic fibrosis (CF); Interstitial lung disease; Non-cystic fibrosis bronchiectasis; Respiratory - Asthma; Respiratory - Chronic obstructive pulmonary disease; Respiratory - Other respiratory disorders / diseases; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12623000559617
• Lead Sponsor: Institute for Respiratory Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-24
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Healthy controls will be recruited from the community via the University of Western Australia. The control subject inclusion criteria are:
1. No history of airflow obstruction or any other lung disease
2.Safe to undergo spirometry as outlined in ATS/ERS guidelines, TSANZ/ANZSRS statements, and usual local spirometry policies.

Respiratory patients will be recruited with the following inclusion criteria:
1. Current outpatient of the Sir Charles Gairdner Hospital Respiratory Department clinics; Asthma, Chronic Cough, COPD, Bronchiectasis, Interstitial Lung Disease and Respiratory Rapid Assessment Clinics.
2. Diagnosed by a respiratory specialist with the stated condition on the basis of compatible symptoms and objective measurements in line with current guidelines.
3. Patients due to undergo prescribed spirometry as part of their clinical care. The control group (no evidence / history of airflow obstruction or other lung disease) are volunteers willing to undergo spirometry and/or EIT.
4. Adults (males and females) over the age of 18.
5. Safe to undergo spirometry as outlined in ATS/ERS guidelines, TSANZ/ANZSRS statements, and usual local spirometry policies.

Exclusion Criteria

1. Individuals in whom spirometry may not be safe in accordance with standard precautions (e.g. recent eye surgery, significant aneurysm) as outlined in the ATS/ERS guidelines, TSANZ/ANZSRS statements, and usual local spirometry policies.
2. Previous episodes of syncope with forced manoeuvres
3. When informed consent cannot robustly be obtained (e.g. significant cognitive impairment, language barrier not readily addressed by independent translator).
4. For control subjects, any past medical history of respiratory disease as identified on the Relevant Medical History Questionnaire.
5. Pregnancy
6. Individuals who have an active implanted device (e.g. cardiac pacemaker, implantable cardioverter-defibrillator, neurostimulator).
7. Individuals with other medical conditions that would practically preclude the use of personal spirometry (e.g. limb weakness from previous stroke)
8. Active primary lung cancer or metastases to the lung
9. Life expectancy less than six months in the opinion of the usual treating specialist
10. Patients enrolled in clinical trials of investigational medical products

Study & Design

• Study Type: Interventional
• Study Design: Not specified