Long Term Effects of Heat and Moisture Exchangers (HMEs)

Study Overview
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Brief Summary
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Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.

Official Title
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Long Term Effects of Heat and Moisture Exchangers (HMEs) (Provox® Life™) on Pulmonary Symptoms in Laryngectomized Patients

Conditions
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Laryngectomy; Status

Intervention / Treatment
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* Device: Provox Life


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Provox Life HME<br>Use of Provox Life HMEs and attachment | Device: Provox Life<br>* Compliant use of Provox Life HMEs<br>|
| No Intervention: Control - No HME<br>Control group is current standard of Care in Brazil, which is not using an HME | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CASA-Q Score | assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact. | Baseline, 3 months, 6 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of involuntary coughs per 24 hours | Patient reported, recorded by tally sheeting | Baseline, 3 months, 6 months, 9 months | 
| Forced Expectoration | Patient reported, recorded by tally sheeting | Baseline, 3 months, 6 months, 9 months | 
| Quality of Life by EQ-5D-5L | 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 | Baseline, 3 months, 6 months, 9 months | 
| Jenkins sleep evaluation questionnaire | Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances | Baseline, 3 months, 6 months, 9 months | 
| Questionnaire to assess Shortness of Breath | from Ackerstaff et al., 1993 | Baseline, 3 months, 6 months, 9 months | 
| Voice handicap Index | patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap. | Baseline, 3 months, 6 months, 9 months | 
| Consumption of medical devices (Number of devices used) | Number of devices used, by use of patient diary recoding number of devices used | Baseline, 3 months, 6 months, 9 months | 
| Study-specific questionnaire to assess number of complications and medical treatments | Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave | Baseline, 3 months, 6 months, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngectomy, Heat and Moisture Exchanger, HME, Pulmonary rehabilitation