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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
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Scientific title
Multicenter investigation of airway oscillometry indices to determine early airway closure and elastic recoil properties after lung transplantation
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Secondary ID [1]
301928
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lung Allograft Dysfunction
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Lung Transplantation
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Condition category
Condition code
Respiratory
316453
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
318209
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Early Detection / Screening
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Comparator / control treatment
Comparison is being made between the various airway oscillometry indices and the gold standard of spirometry.
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Control group
Active
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Outcomes
Primary outcome [1]
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Measurement of airway oscillometry indices R5, R5-19, X5, Ax at specified time intervals after lung transplantation.
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Assessment method [1]
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Timepoint [1]
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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
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Secondary outcome [1]
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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).
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Assessment method [1]
385158
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Timepoint [1]
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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
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Secondary outcome [2]
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Assessment of the lung elastic recoil properties will be determined by X5.
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Assessment method [2]
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Timepoint [2]
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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
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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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Subjects will be excluded if they have a significant language barrier, pain or physical disability at the time of testing.
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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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).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
27/07/2020
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Date of last participant enrolment
Anticipated
25/07/2022
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Actual
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Date of last data collection
Anticipated
24/07/2023
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Actual
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Sample size
Target
160
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment postcode(s) [1]
30882
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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St Vincent's Hospital Darlinghurst
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Address [1]
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390 Victoria Street Darlinghurst, NSW 2016
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Country [1]
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Australia
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Funding source category [2]
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Hospital
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Name [2]
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The Alfred Hospital
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Address [2]
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55 Commercial Rd, Melbourne VIC 3004
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Country [2]
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Darlinghurst
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Address
390 Victoria Street Darlinghurst, NSW 2016
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
306844
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Address [1]
306844
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Country [1]
306844
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306551
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St Vincent's Hospital Human Research Ethics Committee
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Ethics committee address [1]
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97-105 Boundary Street
Darlinghurst NSW 2010
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
306551
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Approval date [1]
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11/11/2019
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Ethics approval number [1]
306551
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Summary
Brief summary
We are performing a cross-sectional and longitudinal analysis of airway oscillometry after lung transplantation. We aim to define airway oscillometry indices in patients who are: Stable, have acute lung allograft dysfunction, baseline lung allograft dysfunction and chronic lung allograft dysfunction. We are interested to define early airway closure and elastic recoil properties of the lung allograft.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr David Darley
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Address
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St Vincent's Hospital, 390 Victoria Street Darlinghurst, NSW 2016
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Country
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Australia
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Phone
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+6 1 28382 1111
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr David Darley
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Address
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St Vincent's Hospital, 390 Victoria Street Darlinghurst, NSW 2016
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Country
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Australia
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Phone
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+61 283821111
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Marshall Plit
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Address
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St Vincent's Hospital, 390 Victoria Street Darlinghurst, NSW 2016
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Country
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Australia
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Phone
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+61 283821111
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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