None listed
Conditions
Brief summary
This trial aims to determine the ability of the PEPtrac to record airway clearance sessions performed at home by adults with cystic fibrosis utilising commonly used positive pressure airway clearance devices when compared to participant self-reports. Participants will use the PEPtrac and an airway clearance device for a one week period, performing a treatment session at least once daily At the completion of each treatment session, participants will complete a treatment diary entry. After one week, participants will also complete a questionnaire examining their experience of using the PEPtrac and any suggested design modifications that they may have.
Interventions
Participants will use the PEPtrac device attached and operating with either the PariPEP S, Aerobika or Acapella DH. Participants will be able to choose which one of the three devices they would like to use. Recruitment is limited to 6 participants per device. Participants will perform at least one treatment session per day over the one week study period. Participants may elect to do more than one treatment session per day if clinically indicated based on participant self-assessment and/or physio
Participants will use the PEPtrac device attached and operating with either the PariPEP S, Aerobika or Acapella DH. Participants will be able to choose which one of the three devices they would like to use. Recruitment is limited to 6 participants per device. Participants will perform at least one treatment session per day over the one week study period. Participants may elect to do more than one treatment session per day if clinically indicated based on participant self-assessment and/or physiotherapist opinion. There is no upper limit to the number of treatment sessions able to be performed each day. Treatments will be self-administered at home. The PariPEP will be used for 6 sets of 15 breaths, aiming for a mid-expiratory pressure of 10-20cmH2O. The Aerobika and Acapella will be used for 4 sets of 15 breaths, with a resistance setting than allows a slightly active expiration with inspiratory:expiratory ratio of 1:3-4. Treatment sessions will last approximately 15 minutes. The PEPtrac will be operating in 'research' mode which means participants do not see the duration of treatment or pressures recorded. Participants will also complete a treatment diary entry at the end of each treatment session, recording the start and finish times and number of breaths and cycles performed.
Sponsors
Nathan Ward
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of cystic fibrosis, attending the Royal Adelaide Hospital Adult Cystic Fibrosis Service
Exclusion criteria
Unable to provide informed consent, inability to understand written English, post lung transplantation, recent positive culture of Burkholderia cepacia or Non-Tuberculosis Mycobacteria, current inpatient, current participation in an interventional trial where modification of their airway clearance technique would be considered a protocol violation, any condition which is considered a contraindication to PEP/OPEP therapy.
Outcome results
None listed