ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

Asthma

Bronchiectasis

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Respiratory

Asthma

Respiratory

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Compliance measurements of airway sizes ranging from small (3-4mm) to large (trachea). Comparisons between diseased and normal airways.

Timepoint [1]

24 months

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6009

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council Project Grant No. 513854

Address [1]

Canberra, Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

Hospital Avenue
Nedlands, Perth 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Hospital Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Level 1 E-Block
Sir Charles Gairdner Hospital 
Hospital Avenue
Nedlands, Perth 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/06/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Jonathan Williamson

Address

Department of Pulmonary Physiology
Level 5 G-Block
Sir Charles Gairdner Hospital
Perth, WA

Country

Australia

Phone

08 9346 3154

Fax

Jonathan.Williamson@health.wa.gov.au

Contact person for scientific queries

Name

Dr Jonathan Williamson

Address

Department of Pulmonary Physiology
Level 5 G-Block
Sir Charles Gairdner Hospital
Perth, WA

Country

Australia

Phone

08 9346 3154

Fax

Jonathan.Williamson@health.wa.gov.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically