Trial Review

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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] 309172 0
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 328595 0
Condition category
Condition code
Respiratory 325609 325609 0 0
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] 325137 0
Not applicable
Comparator / control treatment
Standard in-lab spirometry
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334121 0
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] 334121 0
During a single assessment session.
Secondary outcome [1] 419419 0
Supervised in-lab versus supervised portable spirometry FVC (L) performed via Telehealth.

An in-lab spirometer that is verified and calibrated as per American Thoracic Society/European Respiratory Society guidelines will be used.
Timepoint [1] 419419 0
During a single assessment session.
Secondary outcome [2] 419426 0
Supervised in-lab versus supervised portable spirometer spirometric ratio (FEV1/FVC) performed via Telehealth.

An in-lab spirometer that is verified and calibrated as per American Thoracic Society/European Respiratory Society guidelines will be used.
Timepoint [2] 419426 0
During a single assessment session.
Secondary outcome [3] 419427 0
Supervised in-lab versus supervised portable spirometer ATS performance grade.

An in-lab spirometer that is verified and calibrated as per American Thoracic Society/European Respiratory Society guidelines will be used. Spirometric grade
Timepoint [3] 419427 0
During a single assessment session.
Secondary outcome [4] 419428 0
Portable spirometer calibration check using a 3L syringe at 3 flow rates (low, medium, high) as per ATS/ ERS recommendations.
Timepoint [4] 419428 0
During a single assessment session.

Eligibility
Key inclusion criteria
Children and adults felt to be capable of performing spirometry with an Australian Register of Therapeutic Goods (ARTG) approved home spirometer and a chronic lung disease requiring regular formal spirometry.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

a) No TGA approved home spirometer
b) Behavioural or cognitive disabilities precluding the individual’s ability to perform spirometry

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participant demographics and group lung function data will be reported using descriptive data will be expressed as mean ± SD, unless otherwise stated. Pair-wise comparisons will be tested by paired t-test or Wilcoxon signed-rank test depending on the normality of data distribution. Unpaired t-tests and Mann-Whitney U tests will be used for between group comparisons where appropriate. Bland Altman analysis will be performed to assess agreement between spirometers. A >10% difference in FEV1 %predicted and/or a difference in volume of 0.15L between devices for FEV1 or FVC were considered significant, as these differences indicate a significant clinical change or unacceptable reproducibility respectively. Linear regression will be conducted to investigate possible associations between age, height, spirometry results and the difference between device measurements.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/04/2023
Actual
Date of last participant enrolment
Anticipated
6/03/2024
Actual
Date of last data collection
Anticipated
6/03/2024
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 24248 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 24249 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 24250 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 24251 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 39787 0
2031 - Randwick
Recruitment postcode(s) [2] 39786 0
2050 - Camperdown
Recruitment postcode(s) [3] 39788 0
2145 - Westmead
Recruitment postcode(s) [4] 39789 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312903 0
Self funded/Unfunded
Name [1] 312903 0
Country [1] 312903 0
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Department of Respiratory and Sleep Medicine
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 315130 0
None
Name [1] 315130 0
Address [1] 315130 0
Country [1] 315130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312178 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 312178 0
Name of Institution: Sydney Local Health District
Address: Level 11, KGV Building Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 312178 0
Australia
Date submitted for ethics approval [1] 312178 0
Approval date [1] 312178 0
01/03/2023
Ethics approval number [1] 312178 0
X22-0397 & 2022/ETH02543

Summary
Brief summary
To determine if supervised home spirometry can replace in-lab spirometry when needed, this study will evaluate Australian Register of Therapeutic Goods (ARTG) approved home spirometry quantitative and qualitative performance compared with in-lab spirometry supervised by a respiratory scientist. Older spirometers (> 1 year of use) will have a calibration check to assess ongoing validity of results.

Hypothesis:
a) Supervised outpatient spirometry indices (FEV1, FVC) and grade performed on a personal portable spirometer via Telehealth and standard in-lab spirometry 15 minutes apart in patients with chronic lung disease will be comparable
b) Home spirometers will remain reliable after > 1 year of use
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123750 0
Dr Sheila Sivam
Address 123750 0
Royal Prince Alfred Hospital
Department of Respiratory and Sleep Medicine
Missenden Road
Camperdown NSW 2050
Country 123750 0
Australia
Phone 123750 0
+61 2 9515 8195
Fax 123750 0
+61 2 9515 8196
Email 123750 0
sheila.sivam@health.nsw.gov.au
Contact person for public queries
Name 123751 0
Dr Sheila Sivam
Address 123751 0
Royal Prince Alfred Hospital
Department of Respiratory and Sleep Medicine
Missenden Road
Camperdown NSW 2050
Country 123751 0
Australia
Phone 123751 0
+61 2 9515 8195
Fax 123751 0
+61 2 9515 8196
Email 123751 0
sheila.sivam@health.nsw.gov.au
Contact person for scientific queries
Name 123752 0
Dr Sheila Sivam
Address 123752 0
Royal Prince Alfred Hospital
Department of Respiratory and Sleep Medicine
Missenden Road
Camperdown NSW 2050
Country 123752 0
Australia
Phone 123752 0
+61 2 9515 8195
Fax 123752 0
+61 2 9515 8196
Email 123752 0
sheila.sivam@health.nsw.gov.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?

No Supporting Document Provided



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.