Laryngectomy
Conditions
Keywords
Pulmonary rehabilitation, Quality of Life, Heat and Moisture Exchangers
Brief summary
Background: The benefits of using Heat and Moisture Exchangers (HMEs) for pulmonary rehabilitation after total laryngectomy are widely known. However, current available HMEs do not reach the level of humidification capacity of the nose, and patients adherence to using an HME 24/7 is not always possible. Provox Life HMEs and attachments are a new range of HMEs and attachments, with improved humidification/breathability performance, and designed to suit different situations. Purpose and aim: In this clinical trial, the new Provox Life System was assessed for pulmonary rehabilitation and QoL after total laryngectomy, and compared with currently available HMEs and attachments. Methods: Forty laryngectomized patients, who were previous users of HMEs, were randomized to Usual Care or Provox Life for 6 weeks, after which a cross-over occurred. Data was collected at baseline, and after the end of each study period. Additionally, patients filled in a diary and tally sheet to record their forced expectorations and coughing.
Interventions
DEVICEProvox Life
Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)
DEVICEUsual Care
Continued Usual Care routines.
Sponsors
Atos Medical AB
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single center, randomized, prospective crossover study
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 * Provox XtraHME user * Provox Adhesive user * Longer than 3 months after total laryngectomy * Longer than 6 weeks after postoperative radiotherapy
Exclusion criteria
* Medical problems prohibiting the use of HME or adhesive * Active recurrent or metastatic disease (medical deterioration) * Recent pulmonary infections/unstable pulmonary condition * Reduced mobility of arms and/or hands, unable to remove an HME * Unable to understand the Patient Information and/or unable to give Informed Consent * Insufficient cognitive ability to handle the HME or adhesive * LaryButton users
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average number of forced mucus expectorations per 24 hours | during week 6 of period 1 and period 2 (each period is 6 weeks) | Patient reported, recorded by Tally sheeting on 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coughing Symptoms (COUS) domain score of CASA-Q | Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks) | Cough Symptoms (COUS), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact. |
| Coughing Impact (COUI) domain score of CASA-Q | Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks) | Cough Impact (COUI), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact. |
| Sputum Symptoms (SPUS) domain score of CASA-Q | Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks) | Sputum Symptoms (SPUS), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact. |
| Sputum Impact (SPUI) domain score of CASA-Q | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | Sputum Impact (SPUI), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact. |
| Peristomal skin irritation | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | Recorded by study specific questionnaire on frequency of Skin irritation. |
| Average number of (involuntary) dry coughs per 24 hours | during week 6 of period 1 and period 2 (each period is 6 weeks) | Patient reported, recorded by Tally sheeting on 3 days |
| Quality of Life by EQ-5D-5L | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | 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 |
| Frequency of using sleeping medication | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | Study-specific questionnaire on use of sleeping medications |
| Average number of hours of HME use per 24 hours | during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks) | Patient reported, recorded by daily diary keeping the last two weeks of each study period |
| Situational usage pattern of Provox Life HMEs | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | Study-specific questionnaire about the situational use of devices |
| Patient satisfaction with the Provox Life devices | At the end of Period 1 (Group A), at the end of Period 2 (Group B) (each period is 6 weeks) | Patient satisfaction with devices through study specific questionnaires. |
| Average number of days with skin irritation | during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks) | Patient reported, recorded by daily diary keeping the last two weeks of each study period |
Countries
Italy
Outcome results
None listed