Laryngectomy; Status
Conditions
Keywords
Laryngectomy, Heat and Moisture Exchanger, HME, Pulmonary rehabilitation
Brief summary
Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.
Interventions
DEVICEProvox Life
Compliant use of Provox Life HMEs
Sponsors
Instituto de Cancer Dr Arnaldo
Atos Medical AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Total laryngectomy, irrespective of pharynx reconstruction method * 18 years or older * Longer than 3 months after total laryngectomy * Longer than 6 weeks after postoperative radiotherapy
Exclusion criteria
* Current use of HMEs (within last 3 months) * Medical problems prohibiting the use of HME * Active recurrent or metastatic disease (medical deterioration) * Recent pulmonary infections/unstable pulmonary condition * Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves * Low tidal volumes * Unable to understand the Participant Information and/or unable to give Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CASA-Q Score | Baseline, 3 months, 6 months, 9 months | assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expectoration | Baseline, 3 months, 6 months, 9 months | Patient reported, recorded by tally sheeting |
| Quality of Life by EQ-5D-5L | Baseline, 3 months, 6 months, 9 months | patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility |
| Jenkins sleep evaluation questionnaire | Baseline, 3 months, 6 months, 9 months | Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances |
| Number of involuntary coughs per 24 hours | Baseline, 3 months, 6 months, 9 months | Patient reported, recorded by tally sheeting |
| Voice handicap Index | Baseline, 3 months, 6 months, 9 months | patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap. |
| Consumption of medical devices (Number of devices used) | Baseline, 3 months, 6 months, 9 months | Number of devices used, by use of patient diary recoding number of devices used |
| Study-specific questionnaire to assess number of complications and medical treatments | Baseline, 3 months, 6 months, 9 months | Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave |
| Questionnaire to assess Shortness of Breath | Baseline, 3 months, 6 months, 9 months | from Ackerstaff et al., 1993 |
Countries
Brazil
Outcome results
None listed