None listed
Conditions
Brief summary
The aim of this research project is to investigate whether the type of interface (a face mask or a mouthpiece) used during the measurement of cough strength, called peak cough flow, changes the values obtained. While face masks are commonly used during measurements of cough strength in clinical practice, a mouthpiece can also be used. However, it is unclear whether these interfaces are interchangeable. This is important to know as differences in the measurement of cough strength due to interface type could delay access to therapies to improve cough strength. If an individual is found to have a weak cough, therapies such as a cough assist machine can be used to improve cough effectiveness. Again, both face mask and mouthpiece interfaces are used with the cough assist machine but it is unclear if interface type changes the effectiveness of the cough assist machine. Currently no studies have compared face masks and mouthpieces in the measurement of cough strength in people with respiratory muscle weakness. Similarly, there is no information about how these two interfaces studies effect how cough assist machines perform or how comfortable each interface is to use.
Interventions
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 performe
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.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed