Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000199516
Ethics application status
Approved
Date submitted
23/01/2024
Date registered
29/02/2024
Date last updated
29/07/2024
Date data sharing statement initially provided
29/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between face masks and mouthpieces: effects on measurement of cough strength and use of a cough assist machine
Scientific title
Comparison between oronasal and mouthpiece interfaces: effects on peak cough flow measurement and mechanical insufflation-exsufflation treatment in people with known or suspected respiratory muscle weakness
Secondary ID [1] 311341 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory muscle weakness 332600 0
Neuromuscular disease 332601 0
Condition category
Condition code
Neurological 329297 329297 0 0
Other neurological disorders
Neurological 329298 329298 0 0
Neurodegenerative diseases
Respiratory 329562 329562 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stage 1 of the study
The use of a mouthpiece interface will be compared to an oronasal (face) mask interface during the measurement of unassisted peak cough flow using a peak flow meter in people with known or suspected respiratory muscle weakness. Assessment of unassisted peak cough flow will be:
- performed with participants in the upright seated position
- performed using a nose peg when the mouthpiece interface is being used
- five repetitions of peak cough flow measurement will be performed with each interface, at least 30 seconds apart with at least a five minute rest between interfaces. Each peak cough flow measurement value will be recorded on a data collection form
- performed by a physiotherapist with >7 years experience in the performance of bedside respiratory function tests in people with neuromuscular weakness
- performed in the respiratory outpatient department at Royal Prince Alfred Hospital or in the participant's home
- Stage 1 of the study will be completed during a single visit
- It is anticipated that Stage 1 study procedures will be completed within 20 minutes


Stage 2 of the study
In participants from Stage 1 of the study with reduced cough strength (peak cough flow <270L/min) and where mechanical in-exsufflation is deemed appropriate, the use of a mouthpiece interface will be compared to an oronasal mask interface during mechanical in-exsufflation. Assessment of peak cough flow during mechanical in-exsufflation using a mouthpiece and oronasal mask interface will be:
- performed with participants in the upright seated position
- mechanical in-exsufflation settings will be individually titrated while using an oronasal mask prior to commencing Stage 2 of the study. Settings will then be fixed for the comparison between interfaces
- five repetitions of mechanical in-exsufflation will be performed via each interface and peak cough flow measurement via the mechanical in-exsufflation machine will be recorded on a data collection form. Mechanical in-exsufflation cycles will be performed at least 30 seconds apart with at least a five minute rest between interfaces
- performed by a physiotherapist with >7 years experience in the delivery of mechanical in-exsufflation therapy in people with respiratory muscle weakness
- performed in the respiratory outpatient department at Royal Prince Alfred Hospital or in the participant's home
- Stage 2 of the study will be completed during a single visit. This may be on the same day as Stage 1 of the study, or at the participant's request, on another day
- It is anticipated that Stage 2 study procedures will be completed within 20 minutes

Data from Stage 1 and Stage 2 will be analyzed separately. Participants included in Stage 2 of the study will have completed Stage 1 of the study. However, participants from Stage 1 of the study will only be eligible for Stage 2 of the study if unassisted peak cough flow <270L/min.
Intervention code [1] 327807 0
Treatment: Devices
Intervention code [2] 327808 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will act as their own control (randomised cross-over study) to enable comparison of mouthpiece and oronasal face mask interfaces during measurement of unassisted peak cough flow and measurement of peak cough flow during mechanical in-exsufflation therapy.
Control group
Active

Outcomes
Primary outcome [1] 337155 0
Stage 1: Unassisted peak cough flow (L/min) with the oronasal mask compared to the mouthpiece interface
Timepoint [1] 337155 0
Stage 1: All measures will be completed during a single visit . Unassisted peak cough flow will be recorded on the data collection form immediately after each manoeuvre is performed.
Primary outcome [2] 337156 0
Stage 2: Peak cough flow (L/min) during mechanical in-exsufflation with the oronasal mask compared to the mouthpiece interface
Timepoint [2] 337156 0
Stage 2: All measures will be completed in a single visit (this may be the same visit as Stage 1). Peak cough flow measured using the mechanical in-exsufflation device will be recorded on the data collection form immediately after each manoeuvre is performed.
Secondary outcome [1] 430879 0
Stage 2: Impact of oronasal and mouthpiece interfaces on cough effectiveness during mechanical in-exsufflation.
Timepoint [1] 430879 0
Stage 2: All measures will be completed during a single visit (this may be the same visit as Stage 1). Waveform data will be downloaded after Stage 2 data collection has been completed. Flow-time and pressure-time waveforms will be reviewed for each cough manoeuvre using the oronasal mask and mouthpiece interfaces on the mechanical in-exsufflation device.
Secondary outcome [2] 430880 0
Comparison of real-time peak cough flow (L/min) displayed on the device screen and peak cough flow (L/min) determined by assessment of flow-time waveform data for oronasal mask and mouthpiece interfaces during mechanical in-exsufflation.
Timepoint [2] 430880 0
Stage 2: All measures will be completed during a single visit (this may be the same visit as Stage 1). Peak cough flow measured using the mechanical in-exsufflation device will be displayed on the device screen immediately after the in-exsufflation cycle (i.e. real-time) is performed will be recorded on the data collection form immediately after each manoeuvre. This real-time measure of peak cough flow will be compared to peak cough flow derived from review of the flow-time waveform data, i.e. the first real-time peak cough flow value using the oronasal mask will be compared with the first flow-time waveform peak cough flow value for the oronasal mask and so on. The flow-time waveform data will be downloaded after Stage 2 data collection has been completed. Flow-time waveforms will be reviewed for each cough manoeuvre using the oronasal mask and mouthpiece interfaces on the mechanical in-exsufflation device.
Secondary outcome [3] 430881 0
Stage 1 Participant interface preference: Ease of use
Timepoint [3] 430881 0
Stage 1: All measures will be completed during a single visit. The Ease of use visual analogue scale for the oronasal mask will be completed after the five measures of unassisted peak cough flow using the oronasal mask has been completed, and for the mouthpiece after the five measures of unassisted peak cough flow have been performed using the mouthpiece.
Secondary outcome [4] 431552 0
Stage 2 Participant interface preference: Comfort
Timepoint [4] 431552 0
Stage 2: All measures will be completed during a single visit (this may be the same visit as Stage 1). The Comfort visual analogue scale for the oronasal mask will be completed after the five measures of peak cough flow using the mechanical in-exsufflation device with the oronasal mask has been completed, and for the mouthpiece after the five measures of peak cough flow using the mechanical in-exsufflation device have been performed using the mouthpiece.
Secondary outcome [5] 431557 0
Stage 2 Participant interface preference: Ease of use
Timepoint [5] 431557 0
Stage 2: All measures will be completed during a single visit (this may be the same visit as Stage 1). The Ease of use visual analogue scale for the oronasal mask will be completed after the five measures of peak cough flow using the mechanical in-exsufflation device with the oronasal mask has been completed, and for the mouthpiece after the five measures of peak cough flow using the mechanical in-exsufflation device have been performed using the mouthpiece.
Secondary outcome [6] 431558 0
Stage 2 Participant interface preference: Effectiveness
Timepoint [6] 431558 0
Stage 2: All measures will be completed during a single visit (this may be the same visit as Stage 1). The Effectiveness visual analogue scale for the oronasal mask will be completed after the five measures of peak cough flow using the mechanical in-exsufflation device with the oronasal mask has been completed, and for the mouthpiece after the five measures of peak cough flow using the mechanical in-exsufflation device have been performed using the mouthpiece.

Eligibility
Key inclusion criteria
Stage 1 and Stage 2 of the study:
-Medically stable individuals with suspected or known respiratory muscle weakness who are
greater than or equal to 18 years of age
- Able to provide informed consent and willing to participate and comply with the study requirements

Additional criteria for Stage 2 of the study:
- Free from contraindications to forced manoeuvres or positive pressure ventilation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage 1
- Inability to follow instructions
- Inability to understand written or verbal English
- Inability to obtain a seal lip with a mouthpiece
- Pain or other conditions that may impede cough
- Tracheostomy
- Standard contraindications to forced respiratory manoeuvres

Stage 2
- Standard contraindications to positive pressure therapy

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired oronasal mask and mouthpiece peak cough flow measures will be compared using Bland Altman analysis (Bland & Altman, 1986).
Secondary outcome measures including participant perception of ease of use, comfort and effectiveness of the two interfaces in both Stages will be analysed with paired t-tests to compare mean results of the two measurements. Interface preference in both Stages will be calculated as percentages and analysed using a Chi squared test to compare between the two interfaces.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2024
Actual
10/04/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
43
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26078 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 41933 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 315594 0
Hospital
Name [1] 315594 0
Royal Prince Alfred Hospital
Country [1] 315594 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 317689 0
None
Name [1] 317689 0
Address [1] 317689 0
Country [1] 317689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314485 0
Sydney Local Health District HREC (RPA zone)
Ethics committee address [1] 314485 0
Ethics committee country [1] 314485 0
Australia
Date submitted for ethics approval [1] 314485 0
28/11/2023
Approval date [1] 314485 0
14/02/2024
Ethics approval number [1] 314485 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131754 0
Dr Collette Menadue
Address 131754 0
Sleep Unit, Level 11, Building 75, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 131754 0
Australia
Phone 131754 0
+61 295158708
Fax 131754 0
Email 131754 0
[email protected]
Contact person for public queries
Name 131755 0
Collette Menadue
Address 131755 0
Sleep Unit, Level 11, Building 75, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 131755 0
Australia
Phone 131755 0
+61 295158708
Fax 131755 0
Email 131755 0
[email protected]
Contact person for scientific queries
Name 131756 0
Collette Menadue
Address 131756 0
Sleep Unit, Level 11, Building 75, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 131756 0
Australia
Phone 131756 0
+61 295158708
Fax 131756 0
Email 131756 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
Consent will not be obtained for future use of data


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.