ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000288628

Ethics application status

Approved

Date submitted

10/03/2023

Date registered

17/03/2023

Date last updated

17/03/2023

Date data sharing statement initially provided

17/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None.

Universal Trial Number (UTN)

U1111-1289-2677

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic lung disease

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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.

Intervention code [1]

Not applicable

Comparator / control treatment

Standard in-lab spirometry

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Supervised in-lab versus supervised portable spirometry FEV1(L) performed via Telehealth.

An in-lab spirometer that is verified and calibrated as per American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines will be used.

Timepoint [1]