Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000624482
Ethics application status
Approved
Date submitted
26/11/2007
Date registered
5/12/2007
Date last updated
25/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measuring airway stiffness using optical imaging – a new tool to help understand lung diseases.
Scientific title
Measurements of regional airway compliance using anatomical optical coherence tomography (aOCT) in normal and diseased airways (obstructive lung conditions)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chonic obstructive pulmonary disease 2577 0
Asthma 2578 0
Bronchiectasis 2579 0
Condition category
Condition code
Respiratory 2687 2687 0 0
Chronic obstructive pulmonary disease
Respiratory 2688 2688 0 0
Asthma
Respiratory 2689 2689 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients are anaesthetised and a laryngeal mask airway (LMA) postitioned in the upper airway. A bronchoscope is passed through the LMA into the tracheobronchial tree. A catheter containing a fibre-optic probe is passed through the working channel of the bronchoscope until it is visible beyond the tip of the bronchoscope in a selected airway. Rotation of the probe within the catheter produces a cross sectional image of the airway in much the same as a radar display. Airway cross sectional area measurements are made while simultaneously increasing airway pressures via the anaesthetic circuit. The slope of the pressure vs cross sectional area plot is a measure of the compliance of the airway at that particular site. This process is repeated a number of times in small and large airways of the tracheo-bronchial tree.
Intervention code [1] 2313 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3590 0
Compliance measurements of airway sizes ranging from small (3-4mm) to large (trachea). Comparisons between diseased and normal airways.
Timepoint [1] 3590 0
24 months
Secondary outcome [1] 6013 0
Comparisons of large airway compliance in healthy and abnormal lungs and their relationship to bronchomalacia and sputum retention. Compliance curves will be constructed by plotting the relationship between cross sectional area (as measured using OCT) and pressure (which will be applied via the anaesthetic circuit). The curves will be described in terms of absolute compliance (slope of the curve) and by applying the data to a mathematical exponential equation to derive the shape factor (Colebatch shape factor K).
Timepoint [1] 6013 0
24 months

Eligibility
Key inclusion criteria
Age >18yrs
Fit for bronchoscopy
Asthma or chronic obstructive pulmonary disease or bronchiectasis or healthy non-smoker
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age <18yrs
Unfit for bronchoscopy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 499 0
6009

Funding & Sponsors
Funding source category [1] 2839 0
Government body
Name [1] 2839 0
National Health and Medical Research Council Project Grant No. 513854
Country [1] 2839 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands, Perth 6009
Country
Australia
Secondary sponsor category [1] 2579 0
None
Name [1] 2579 0
Address [1] 2579 0
Country [1] 2579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4759 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 4759 0
Human Research Ethics Committee
Level 1 E-Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, Perth 6009
Ethics committee country [1] 4759 0
Australia
Date submitted for ethics approval [1] 4759 0
Approval date [1] 4759 0
28/06/2007
Ethics approval number [1] 4759 0
2007-064

Summary
Brief summary
The purpose of this study is to evaluate the clinical usefulness of a new diagnostic laser that has been developed at the University of Western Australia. The device is an imaging tool that can make various measurements of the inside of the lungs to help improve our understanding of the lungs in health and disease. Current lung function tests give us information about the lungs as a whole but do not tell us about specific regions within the lungs. Most lung disorders affect different parts of the lungs and to different degrees. Many of these changes are related to the varying degrees of “stiffness” within the air tubes, but at present doctors don’t have adequate tools to measure this airway property.
We have developed an optical imaging technique that we think may provide a way to measure these properties. The system has been developed by two research groups, the West Australian Sleep Disorders Research Institute at Sir Charles Gairdner Hospital and the Optical and Biomedical Engineering Laboratory at the University of Western Australia. We have had encouraging results using this device in the upper airway (throat) of awake, sleeping and anaesthetised volunteers and have started using it in patients with windpipe cancers to improve their care. We would now like to use the system to make measurements of airway “stiffness” which we think will help understand lung diseases such as asthma, chronic obstructive pulmonary disease and bronchiectasis.
Trial website
Trial related presentations / publications
An abstract describing preliminary results has been submitted to the 2009 American Thoracic Society annual meeting in San Diego in May and to the Thoracic Society of Australia and NZ annual scientific meeting in April.
Public notes

Contacts
Principal investigator
Name 28209 0
Address 28209 0
Country 28209 0
Phone 28209 0
Fax 28209 0
Email 28209 0
Contact person for public queries
Name 11366 0
Dr Jonathan Williamson
Address 11366 0
Department of Pulmonary Physiology
Level 5 G-Block
Sir Charles Gairdner Hospital
Perth, WA
Country 11366 0
Australia
Phone 11366 0
08 9346 3154
Fax 11366 0
Email 11366 0
[email protected]
Contact person for scientific queries
Name 2294 0
Dr Jonathan Williamson
Address 2294 0
Department of Pulmonary Physiology
Level 5 G-Block
Sir Charles Gairdner Hospital
Perth, WA
Country 2294 0
Australia
Phone 2294 0
08 9346 3154
Fax 2294 0
Email 2294 0
[email protected]

No information has been provided regarding IPD availability


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.