Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000224123
Ethics application status
Approved
Date submitted
11/02/2019
Date registered
15/02/2019
Date last updated
15/10/2021
Date data sharing statement initially provided
15/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Modified forced expiration technique using expiratory resistance in adults with cystic fibrosis: A pilot study.
Scientific title
Measuring the impact of a modified forced expiration technique using expiratory resistance on ease of expectoration, sputum wet weight and cough frequency in adults with cystic fibrosis.
Secondary ID [1] 297290 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MFET-CF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 311463 0
Condition category
Condition code
Respiratory 310103 310103 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 310147 310147 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design of this trial will be a randomised crossover trial. The study will consist of a morning and afternoon treatment (single day) consisting of 10 cycles of the participant’s usual airway clearance techniques (ACT). Each session will last approximately 30 minutes and the washout period will be at least 2 hours between sessions. Half (5) of the forced expiratory technique (FET) components will be performed with an expiratory resistance device (ERD), the other half will consist of the FET alone. The two FET methods will be alternated throughout each cycle in the session. There is no time period between airway clearance cycles, the patient will continue onto the next cycle as soon as they have caught their breath following the FET and cough.

The expiratory resistance device will consist of a mask which provides positive expiratory pressure which aims to increase airway stability during a forced expiratory technique. The forced expiratory technique (otherwise termed a huff) is a form of airway clearance similar to a cough but requires less force, is less fatiguing and targets secretions from distal airways.

Participants will be randomly allocated to perform the FET with the ERD or without the ERD and will alternate from the variable starting points. This will be repeated in the afternoon session, however the first cycle will start with the opposite FET method to the morning session.

Ease of expectoration during the FET will be measured using a Visual Analogue Scale (VAS) following each cycle. The number of coughs will also be measured following each cycle. Sputum wet weight for each FET method and patient preference will be documented at the end of each session. Adherence to the intervention will be monitored by direct observation by study personnel.
Intervention code [1] 313612 0
Treatment: Other
Comparator / control treatment
Randomised cross-over study with participants acting as their own control
Control group
Active

Outcomes
Primary outcome [1] 319020 0
Ease of expectoration - measured using a 10 cm VAS.
Timepoint [1] 319020 0
Measured after every ACT cycle
Secondary outcome [1] 366737 0
Sputum wet weight - measured on an Adam Equipment Nimbus Precision NBL 423e calibrated to 0.001g.
Timepoint [1] 366737 0
Measured after each ACT session.
Secondary outcome [2] 366738 0
Number of coughs in each cycle throughout session - will be manually counted by the treating therapist.
Timepoint [2] 366738 0
Counted during each cycle.

Eligibility
Key inclusion criteria
People with CF who: (i) are aged 18 years and; (ii) are admitted to the Respiratory Medicine ward at SCGH for an acute exacerbation of CF.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) the inability to provide written informed consent; (ii) haemoptysis; (iii) use of non-invasive ventilation; (iv) pneumothorax and; (v) inability to expectorate sputum.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer generated randomisation sequence with the group allocation placed in opaque envelopes will be used to provide allocation concealment. The envelope will be selected by a member of the research team who will not be involved with the treatment session or data collection. This will minimise the risk of selection bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using SPSS (Version 22, SPSS, Chicago, IL, USA). The distribution of data will be checked for normality using frequency histograms and Shapiro-Willk test. A p value of < 0.05 will be considered statistically significant. The data will be analysed with an independent samples t-test or Mann-Whitney U test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
1/10/2019
Date of last participant enrolment
Anticipated
29/10/2021
Actual
Date of last data collection
Anticipated
12/11/2021
Actual
Sample size
Target
20
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13087 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 25596 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 301850 0
Hospital
Name [1] 301850 0
Sir Charles Gairdner Hospital
Country [1] 301850 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
2 Hospital Avenue, Nedlands, Perth, WA. 6009.
Country
Australia
Secondary sponsor category [1] 301683 0
None
Name [1] 301683 0
Address [1] 301683 0
Country [1] 301683 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302611 0
Department of Health WA Human Research Ethics Committee [EC00422]
Ethics committee address [1] 302611 0
PO Box 8172
Perth Business Centre
Perth WA 6849
Ethics committee country [1] 302611 0
Australia
Date submitted for ethics approval [1] 302611 0
25/02/2019
Approval date [1] 302611 0
09/09/2019
Ethics approval number [1] 302611 0

Summary
Brief summary
The development of an effective airway clearance regimen is important to minimise development of irreversible airway obstruction in people with cystic fibrosis. Positive expiratory pressure (PEP) is often used as it helps to provide resistance during expiration, improve collateral ventilation and aid in the shearing of mucus from airways. The use of PEP and other expiratory resistive devices (ERD) as airway clearance techniques (ACT) in this population is well established in the literature but there is no literature which looks at the use of an ERD combined with masks during huffing, to improve sputum clearance. The proposed study will investigate the effect of using an ERD during a huff on ease of expectoration, sputum volume, and coughing, when compared to a huff without resistance.
The hypothesis is that using an ERD during a huff will improve ease of expectoration, sputum volume and reduce amount of coughing required.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90610 0
Mrs Kathryn Watson
Address 90610 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
Perth WA
6009
Country 90610 0
Australia
Phone 90610 0
+61 8 64572337
Fax 90610 0
Email 90610 0
[email protected]
Contact person for public queries
Name 90611 0
Mrs Kathryn Watson
Address 90611 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
Perth WA
6009
Country 90611 0
Australia
Phone 90611 0
+61 8 64572337
Fax 90611 0
Email 90611 0
[email protected]
Contact person for scientific queries
Name 90612 0
Mrs Kathryn Watson
Address 90612 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
Perth WA
6009
Country 90612 0
Australia
Phone 90612 0
+61 8 64572337
Fax 90612 0
Email 90612 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
SourceTitleYear of PublicationDOI
EmbaseModified forced expiration technique using expiratory resistance in adults with cystic fibrosis.2023https://dx.doi.org/10.1111/crj.13708
N.B. These documents automatically identified may not have been verified by the study sponsor.