Trial Review

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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
ACTRN12624000436572
Ethics application status
Approved
Date submitted
18/03/2024
Date registered
10/04/2024
Date last updated
10/04/2024
Date data sharing statement initially provided
10/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the effect of airway clearance techniques in adults with bronchiectasis.
Scientific title
Feasibility of Electrical Impedance Tomography in assessing short-term effects of airway clearance techniques in adults with bronchiectasis.
Secondary ID [1] 311759 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 333262 0
Condition category
Condition code
Respiratory 329953 329953 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electrical impedance tomography (EIT) monitoring during airway clearance techniques for those participants included in the study.
An electrode belt connected to EIT machine will be placed on the participant’s chest, the belt is worn at nipple level for males and below the breast tissues for females (between 4th and 6th intercostal space). EIT belt positioning is marked on the skin with a marker to ensure its fixed displacement during the measurement period.
Baseline measures of oxygen saturation will be recorded via pulse oximeter. EIT measurements will commence 5 minutes before ACTs and continue for the duration of the session.
Participants will then perform their routine ACTs for up to 20mins (participants either complete their routine ACTs within 20mins or are requested to stop at 20mins). The ACTs performed were previously prescribed by their treating physiotherapist and are individualised. Airway clearance may involve breathing exercises, positive expiratory pressure (PEP) or oscillatory PEP devices, or a combination of inhaled therapy with devices.
Details of ACTs performed by each participant will be collected.
Sputum expectorated during and immediately after the ACTs are collected and measured. Oxygen saturation will be recorded again immediately after the ACTs.
EIT measurements will cease 5 minutes after ACTs.
After the measurements, participants complete a questionnaire regarding their ACTs experiences and rate whether the EIT measurements affected their ACTs.
Intervention code [1] 328214 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337715 0
centre of ventilation (COV),
Assessment method [1] 337715 0
Electrical Impedance Tomography
Timepoint [1] 337715 0
From 5 minutes prior to intervention until 20 minutes post intervention
Primary outcome [2] 337795 0
Global Inhomogeneity index
Assessment method [2] 337795 0
Electrical Impedance Tomography
Timepoint [2] 337795 0
From 5 mins prior to intervention until 20 minutes post intervention
Primary outcome [3] 337796 0
end-expiratory lung impedance (EELI)
Assessment method [3] 337796 0
Electrical Impedance Tomography
Timepoint [3] 337796 0
From 5 min prior until 20 minutes post intervention
Secondary outcome [1] 432927 0
Oxygen saturation
Assessment method [1] 432927 0
Pulse oximetry
Timepoint [1] 432927 0
Immediately Pre up to 20 min post intervention
Secondary outcome [2] 432928 0
To document the sputum volume produced as a result of the airway clearance techniques (ACTs).
Assessment method [2] 432928 0
Sputum produced during and immediately after ACTs will be collected in 15ml specimen jars. Reading of the scale mark will be recorded as sputum volume.
Timepoint [2] 432928 0
Up to 20 min post intervention
Secondary outcome [3] 432929 0
Dyspnoea scale.
Assessment method [3] 432929 0
Dyspnoea scale
Timepoint [3] 432929 0
Up to 20 min post intervention

Eligibility
Key inclusion criteria
Study participants will be recruited from patients attending the Adult Bronchiectasis Clinic at Mater Hospital Brisbane.
Has a diagnosis of bronchiectasis
• Productive of secretions that require routine airway clearance
• Performs ACTs regularly at home
• Willing and able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Contraindicated for ACTs, including chest trauma, facial trauma or facial burns, bleeding disorder, uncontrolled bronchospasm, and current haemoptysis.
• Contraindicated for EIT measurements, including pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps.
• Inability to follow instructions.
• Patients less than 18 years of age.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis of the EIT raw data will be repeated measures ANOVA analysis using SPSS (IBM® SPSS® software). The primary endpoints are changes of the EIT data on EELI, GI index, COV, IR, and regional impedance amplitudes pre- and post-AC.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26285 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 42256 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 316094 0
Hospital
Name [1] 316094 0
Mater Health
Country [1] 316094 0
Australia
Primary sponsor type
Hospital
Name
Mater Health Brisbane
Country
Australia
Secondary sponsor category [1] 318261 0
University
Name [1] 318261 0
Australian Catholic University
Country [1] 318261 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314916 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 314916 0
Ethics committee country [1] 314916 0
Australia
Date submitted for ethics approval [1] 314916 0
09/11/2023
Approval date [1] 314916 0
06/03/2024
Ethics approval number [1] 314916 0
HREC/MML/103953 (V2)
Ethics committee name [2] 314917 0
Australian Catholic University
Ethics committee address [2] 314917 0
Ethics committee country [2] 314917 0
Australia
Date submitted for ethics approval [2] 314917 0
11/03/2024
Approval date [2] 314917 0
Ethics approval number [2] 314917 0
2024-3335R

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 133134 0
Dr Judith Hough
Address 133134 0
Australian Catholic University, Brisbane Campus, 1100 Nudgee Rd, Banyo Queensland 4014
Country 133134 0
Australia
Phone 133134 0
+61422404369
Email 133134 0
judith.hough@acu.edu.au
Contact person for public queries
Name 133135 0
Judith Hough
Address 133135 0
Australian Catholic University, Brisbane Campus, 1100 Nudgee Rd, Banyo Queensland 4014
Country 133135 0
Australia
Phone 133135 0
+61422404369
Email 133135 0
judith.hough@acu.edu.au
Contact person for scientific queries
Name 133136 0
Judith Hough
Address 133136 0
Australian Catholic University, Brisbane Campus, 1100 Nudgee Rd, Banyo Queensland 4014
Country 133136 0
Australia
Phone 133136 0
+61422404369
Email 133136 0
judith.hough@acu.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• anyone who wishes to access it

Conditions for requesting access:
• -

What individual participant data might be shared?
• Statistical analysis

What types of analyses could be done with individual participant data?
• Meta-analysis

When can requests for individual participant data be made (start and end dates)?
From:
From project completion with no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• https://acuresearchbank.acu.edu.au/

Are there extra considerations when requesting access to individual participant data?
No


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.