Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000559617
Ethics application status
Approved
Date submitted
12/12/2022
Date registered
24/05/2023
Date last updated
30/05/2024
Date data sharing statement initially provided
24/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Personal Spirometer and Electrical Impedance Tomography: agreement with clinic attendance tests (SpiroEIT)
Scientific title
Comparison of personal ultrasonic spirometry and electrical impedance tomography with clinic spirometry for feasibility of use of home monitoring for chronic lung disease.
Secondary ID [1] 308580 0
Nil
Universal Trial Number (UTN)
Trial acronym
SpiroEIT01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 328478 0
Chronic obstructive pulmonary disease (COPD) 328479 0
Cystic fibrosis (CF) 328480 0
Interstitial lung disease 328481 0
Non-cystic fibrosis bronchiectasis 328627 0
Condition category
Condition code
Respiratory 325513 325513 0 0
Asthma
Respiratory 325514 325514 0 0
Chronic obstructive pulmonary disease
Respiratory 325515 325515 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 325631 325631 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The materials provided to the patient are as follows
• Participant information sheet (sent via email, hard copy provided on first appointment)
• Consent form (signed hard copy to take home)
• Harry Perkins Map (sent via email)
• Participant Instruction Sheet (hard copy to take home)
• SpiroHome device, with 2x AAA batteries and single patient use mouthpiece
• Email links and information on how to download the SpiroHome app

Potential participants are identified by their treating respiratory team. Healthy participants volunteer themselves through contacting our investigator phone number found on flyers around the University of Western Australia, or Sir Charles Gairdner Hospital staff areas. If they have expressed interest in research and consent to their contact details to be provided to us, we contact them by phone call.

On phone contact, participants are verbally informed about the study aims and requirements, and have the opportunity to ask questions. If they express interest and consent, they are screened for study eligibility over the phone and an email is sent to them with the Participant Information sheet and a Harry Perkins Map. If agreeable and eligible for the study, participants are enrolled and a date is set for their first appointment. A text reminder is sent to them the week of their appointment with the option to cancel, reschedule, or confirm attendance.

On arrival to their first appointment, the study is discussed in detail with the opportunity for participants to ask questions. Participants receive a hard copy of the Participant Information sheet and Participant Instruction Sheet and are encouraged to read it. Two consent forms are signed by both researcher and participant, allowing both to maintain an original. Participant weight and height are then recorded, and they are randomised into either Desktop spirometry first or SpiroHome device first.

Participants are then coached in spirometry and receive the physical materials of:
1. SpiroHome device (bluetooth-linked to mobile app SpiroHome, and to the confidential clinician/researcher platform: SpiroCloud database)
2. 2 x AAA batteries within the device
3. Single patient use disposable mouthpiece
And receive the free software material downloaded through their smart phone of:
1. SpiroHome application (InoFab)
After completing Spirometry on both the Desktop and SpiroHome device. Participants will then be asked to do part B of the study if they consented to that part. Electrodes will be attached to the participant in a single (16) and or multiple (32) plane around the chest. Once the electrodes are connected to the participant, system checks will occur with the software to ensure it is working. Researcher will instruct participant to have 5 min of normal breathing and then various gentle deep breaths. This only happens during clinic visit 1 and will take approximately 15mins.

The outcomes of the part B will be sex, height, chest circumference, delta impedance (ventilation/lung aeration) during tidal and deep breathing. Global inhomogeneity index (standard deviation of impedance divided by median impedance for given lung region will also be assessed. This will only happen at clinic visit 1.

Participants are booked for their next appointment in 3 weeks for part A only. Participants are advised to undergo spirometry on their SpiroHome device at their convenience, twice weekly for the following 3 weeks. At their second and final appointment, participants return their SpiroHome device, complete a written Exit Questionnaire, and are given $20 in cash for reimbursement of their parking and petrol.

The intervention during the appointments are delivered by either:
Interventions in the community (spirometry on the SpiroHome device) are administered by the participant only.

First clinic appointment: Spirometry on Desktop device, and Spirometry on SpiroHome device. Time commitment 45 minutes.
Twice weekly home spirometry at the participants leisure, on the SpiroHome device (total of 6). Time commitment 5 minutes each.
Second clinic appointment: Return of the spirometer and completion of exit survey and reimbursement: time commitment 10 minutes

Location of Clinic appointments:
Institute of Respiratory Health, level 2 clinic rooms, The Harry Perkins Institute, 6 Verdun st, Nedlands 6009
Location of spirometry in the community: at the participants discretion.

Adherence and spirometry technique are secondary trial outcomes which are being measured. We actively avoid assessing adherence and technique outcomes during the community intervention period in order to prevent investigator bias and get “real world” data on participants. Following data collection, we assess adherence and technique through the SpiroCloud platform where the participants SpiroHome data including date and time of spirometry, and whether they reached American Thoaric Society/European Respiratory Society (ATS/ERS) acceptability and repeatability criteria for each spirometry manoeuvre, is confidentially stored. Participants have access to their own data through their SpiroHome apps and have the option to download PDF print-outs through the SpiroHome app.

Participants are given the option to participate in either Part A alone, or both Parts A and B.

We have deemed it important to randomise participants on their first clinical appointment into whether they receive Desktop Spirometry first, or SpiroHome spirometry first. This will reduce the influence spirometry coaching will have on the data and the number of spirometry trials required to achieve ATS/ERS acceptability and repeatability criteria.
Intervention code [1] 325048 0
Treatment: Devices
Comparator / control treatment
- 20 control subjects with no known lung disease
No historical data is sought outside what the participant verbally informs us, that is; their demographics, smoking status, current medications and whether they have an active respiratory diagnosis. Spirometry assessments will be conducted on 20 control participants.
Control group
Active

Outcomes
Primary outcome [1] 333358 0
Compare the accuracy of the Bird Spirohome device with gold standard spirometry via desktop spirometer (Medgraphics Breeze Suite) across a range of respiratory conditions and healthy controls.
The parameters that will be assessed are FEV1, FVC and FEV1/FVC
Timepoint [1] 333358 0
The primary timepoint is the initial clinic visit i.e. week 1 of the trial. At this point, the participant does spirometry on both the desktop spirometer (gold standard) and the Spirohome portable spirometer device. Order of spirometry tests on the two devices (i.e. Spirohome first versus desktop first) will be randomised to prevent coaching bias.
Primary outcome [2] 333359 0
Accuracy is being assessed between spirometry devices only. Agreement between FEV1 between desktop and Spirohome devices will be assessed using Bland-Altman plots.
Timepoint [2] 333359 0
The primary outcome will be assessed on the initial visit only (Week 1, primary timepoint).
Primary outcome [3] 334400 0
Accuracy is being assessed between spirometry devices only. Agreement between FVC between desktop and Spirohome devices will be assessed using Bland-Altman plots.
Timepoint [3] 334400 0
The primary outcome will be assessed on the initial visit only (Week 1, primary timepoint).
Secondary outcome [1] 416743 0
Participants will complete an Exit Survey which contains questions pertaining to the feasibility of use of the device on a scale of 0-4 with 0 being strongly disagree and 4 being strongly agree. This will be done at Clinic Visit 2. Please see attached exit survey.
Timepoint [1] 416743 0
Measurements will be taken at home between the initial clinic visit at week 1 and the second (and final) clinic visit at week 3 (completion timepoint). We ask participants to do two unsupervised spirometry tests per week, for three weeks (total of 6 tests) in the community.
Secondary outcome [2] 420517 0
The quality rating given by the software, as viewed on the linked SpiroCloud clinician platform. Quality will be assessed by ERS/ATS guidelines during each test.
Timepoint [2] 420517 0
Quality rating is given at the time of testing at each point.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23713 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 39149 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312830 0
Commercial sector/Industry
Name [1] 312830 0
Novartis
Country [1] 312830 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Respiratory Health
Address
Institute for Respiratory Health
QQ Block, QE2 Medical Centre
Level 2, 6 Verdun Street, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 314470 0
None
Name [1] 314470 0
Address [1] 314470 0
Country [1] 314470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312107 0
Bellberry HREC
Ethics committee address [1] 312107 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 312107 0
Australia
Date submitted for ethics approval [1] 312107 0
Approval date [1] 312107 0
24/05/2022
Ethics approval number [1] 312107 0
HREC_2022-03-293

Summary
Brief summary
New home spirometer devices (the SpiroHome device) have not yet been tested for accuracy compared to hospital-standard devices. We are assessing the accuracy of new home spirometers, and whether they are easy to use in the community. Participants also have the option to trial new technology called "EIT" which looks at ventilation across the lung using sensors placed on the skin.
Trial website
Trial related presentations / publications
Public notes
Candidates who test positive to COVID-19 either by rapid antigen test or PCR, or have symptoms suggestive of COVID-19 will be deferred. They will be re-contacted >2 weeks following the positive test result if recruitment is still ongoing.

Contacts
Principal investigator
Name 123502 0
Dr John Blakey
Address 123502 0
Sir Charles Gairdner Hospital
Department of Respiratory Medicine, Hospital Avenue, NEDLANDS WA 6009
Country 123502 0
Australia
Phone 123502 0
+61 08 6457 3249
Fax 123502 0
Email 123502 0
john.blakey@curtin.edu.au
Contact person for public queries
Name 123503 0
Ms Meagan Shorten
Address 123503 0
Institute for Respiratory Health
QQ Block, QE2 Medical Centre, Level 2,
6 Verdun Street
Nedlands WA
6009
Country 123503 0
Australia
Phone 123503 0
+61861510944
Fax 123503 0
Email 123503 0
meagan.shorten@resphealth.uwa.edu.au
Contact person for scientific queries
Name 123504 0
A/Prof Peter Noble
Address 123504 0
The University of Western Australia (M309),
35 Stirling Highway,
Nedlands WA 6009
Australia
Country 123504 0
Australia
Phone 123504 0
+61401 113 582
Fax 123504 0
Email 123504 0
peter.noble@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19185Other    Exit Survey Attached 385111-(Uploaded-17-05-2023-18-55-38)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.