A Multi-centre, Prospective Observational Study comparing Supervised Personal versus In-Lab Spirometry in Adults and Children with a Chronic Lung Disease

This prospective observational study will compare objective spirometer indices (FEV1, FVC) and grade with portable personal spirometers via Telehealth and in-lab spirometry in an outpatient setting. This will occur at the patient’s routine clinic appointment, where they will be advised to bring in their own home spirometer. This initiative will be part of each laboratory’s quality control practice. Only TGA approved portable home spirometers will be included in this study. Participants will only need to partake in testing and device calibration once. This will all occur during the same face to face visit. No additional assessments will be required after that. Patients who meet the inclusion and exclusion criteria will be invited to participate in the study, and will use their existing personal home spirometer. Consent will be obtained from all patients/guardian where applicable. Respiratory scientists will perform a portable spirometer calibration check will prior to the participant performing spirometry on the device. Patients will then perform in-lab or portable pre-bronchodilator home spirometry via Telehealth in random order, supervised by a respiratory scientist in an accredited respiratory function laboratory equipped to perform complex lung function in either the paediatric or adult setting. To mimic the telehealth mode of home spirometry and still allow for testing of devices within 15 minutes of each other, spirometry via Telehealth will be performed with the patient in their clinic room during their outpatient hospital visit and the respiratory scientist supervising spirometry from a different location in the hospital. An additional 15-20 minutes is anticipated to be required to complete spirometry using both in-lab and portable spirometry. Respiratory scientists will ensure that a standardized approach to performing spirometry as per the American Thoracic Society/European Respiratory Society Technical Statement will be undertaken for both in-lab and spirometry via telehealth. Testing will occur in a quiet and comfortable environment that is separated from the waiting room and other patients being tested. The patient should be seated erect, with shoulders slightly back and chin slightly elevated. A smaller chair or a raised footstool may be required for children and small adults.