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Trial registered on ANZCTR


Registration number
ACTRN12620001351909
Ethics application status
Approved
Date submitted
31/07/2020
Date registered
14/12/2020
Date last updated
14/12/2020
Date data sharing statement initially provided
14/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Airway oscillometry after lung transplantation
Scientific title
Multicenter investigation of airway oscillometry indices to determine early airway closure and elastic recoil properties after lung transplantation
Secondary ID [1] 301928 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lung Allograft Dysfunction 318446 0
Lung Transplantation 318447 0
Condition category
Condition code
Respiratory 316453 316453 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
Two separate cohorts will be enrolled:
1. Cross-sectional Cohort: One single airway oscillometry will be performed for any patient presenting to the lung clinic > 3 months after lung transplantation. This cohort will attend a single observation session of approximately 30 minutes duration. Participants will be observed during a single study visit of no more than 30 minutes with no further observation
2. Longitudinal Cohort: Measurement of airway oscillometry indices, spirometry and lung volumes with plethysmography will be performed at regular intervals after Lung Transplantation: At 3 months, 6 months and 12 months after transplant. This cohort will attend a three observation sessions of approximately 45 minutes duration. Participants will be observed during 3 study visits of no more than 45 minutes each.

Airway oscillometry details: Participants will be asked to complete both an impulse oscillometry measurement and a spirometry assessment. Both tests involve breathing into a piece of equipment for 20-30 seconds whilst wearing a nose clip. Within an observation session three 30 second repetitions will be performed with a 30 second break in between each.

The observation sessions will be performed by research assistants trained in the performance of lung function testing and airway oscillometry.
Intervention code [1] 318209 0
Early Detection / Screening
Comparator / control treatment
Comparison is being made between the various airway oscillometry indices and the gold standard of spirometry.
Control group
Active

Outcomes
Primary outcome [1] 324607 0
Measurement of airway oscillometry indices R5, R5-19, X5, Ax at specified time intervals after lung transplantation.
Timepoint [1] 324607 0
Cross-Sectional Cohort: 1 time point > 3 months after lung transplantation
Longitudinal Cohort: 3 time points at 3 months, 6 months and 12 months after lung transplantation
Secondary outcome [1] 385158 0
Assessment of the trajectory of airway closure will be determined by closure at %-total lung capacity (TLC). To determine closure at %-TLC, we will compare compare two derecruitment markers on the Xrs versus volume curve, the onset reduction of Xrs (DR1vol) and the onset of more rapid reduction of Xrs (DR2vol).
Timepoint [1] 385158 0
Cross-Sectional Cohort: 1 time point > 3 months after lung transplantation
Longitudinal Cohort: 3 time points at 3 months, 6 months and 12 months after lung transplantation
Secondary outcome [2] 389661 0
Assessment of the lung elastic recoil properties will be determined by X5.
Timepoint [2] 389661 0
Cross-Sectional Cohort: 1 time point > 3 months after lung transplantation
Longitudinal Cohort: 3 time points at 3 months, 6 months and 12 months after lung transplantation

Eligibility
Key inclusion criteria
We will recruit all post-operative lung transplant recipients who present to the hospital for routine surveillance over a 24 months period. Patients will be identified as appropriate for the study by the primary investigators. Written informed consent will be obtained by the primary investigators and study coordinators at each site.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if they have a significant language barrier, pain or physical disability at the time of testing.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be performed using GraphPad Prism/SPSS. Statistical significance will be defined as p<0.05. Baseline patient characteristics will be compared using the Two-sample Student t-test for continuous variables and Chi-square test for categorical variables. Testing for normality of data distribution will be performed with the Kolmogorov-Smirnov method. Measurement of airway oscillometry indices will be defined using descriptive statistics including median and interquartile range (IQR), and mean with standard deviation (SD). Oscillometry indices will be compared between difference lung allograft phenotypes using one-way analysis of variance (ANOVA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/07/2020
Date of last participant enrolment
Anticipated
25/07/2022
Actual
Date of last data collection
Anticipated
24/07/2023
Actual
Sample size
Target
160
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 30882 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 30883 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 306341 0
Hospital
Name [1] 306341 0
St Vincent's Hospital Darlinghurst
Country [1] 306341 0
Australia
Funding source category [2] 306342 0
Hospital
Name [2] 306342 0
The Alfred Hospital
Country [2] 306342 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Darlinghurst
Address
390 Victoria Street Darlinghurst, NSW 2016
Country
Australia
Secondary sponsor category [1] 306844 0
None
Name [1] 306844 0
Address [1] 306844 0
Country [1] 306844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306551 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 306551 0
Ethics committee country [1] 306551 0
Australia
Date submitted for ethics approval [1] 306551 0
Approval date [1] 306551 0
11/11/2019
Ethics approval number [1] 306551 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104258 0
Dr David Darley
Address 104258 0
St Vincent's Hospital, 390 Victoria Street Darlinghurst, NSW 2016
Country 104258 0
Australia
Phone 104258 0
+6 1 28382 1111
Fax 104258 0
Email 104258 0
[email protected]
Contact person for public queries
Name 104259 0
David Darley
Address 104259 0
St Vincent's Hospital, 390 Victoria Street Darlinghurst, NSW 2016
Country 104259 0
Australia
Phone 104259 0
+61 283821111
Fax 104259 0
Email 104259 0
[email protected]
Contact person for scientific queries
Name 104260 0
Marshall Plit
Address 104260 0
St Vincent's Hospital, 390 Victoria Street Darlinghurst, NSW 2016
Country 104260 0
Australia
Phone 104260 0
+61 283821111
Fax 104260 0
Email 104260 0
[email protected]

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.