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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)
Continued Usual Care routines.
Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'
Roma, Italy
Average number of forced mucus expectorations per 24 hours
Patient reported, recorded by Tally sheeting on 3 days
Time frame: during week 6 of period 1 and period 2 (each period is 6 weeks)
Average number of (involuntary) dry coughs per 24 hours
Patient reported, recorded by Tally sheeting on 3 days
Time frame: during week 6 of period 1 and period 2 (each period is 6 weeks)
Coughing Symptoms (COUS) domain score of CASA-Q
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.
Time frame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Coughing Impact (COUI) domain score of CASA-Q
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.
Time frame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Sputum Symptoms (SPUS) domain score of CASA-Q
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.
Time frame: Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)
Sputum Impact (SPUI) domain score of CASA-Q
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.
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Peristomal skin irritation
Recorded by study specific questionnaire on frequency of Skin irritation.
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Average number of days with skin irritation
Patient reported, recorded by daily diary keeping the last two weeks of each study period
Time frame: during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
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
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Frequency of using sleeping medication
Study-specific questionnaire on use of sleeping medications
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Average number of hours of HME use per 24 hours
Patient reported, recorded by daily diary keeping the last two weeks of each study period
Time frame: during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks)
Situational usage pattern of Provox Life HMEs
Study-specific questionnaire about the situational use of devices
Time frame: Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)
Patient satisfaction with the Provox Life devices
Patient satisfaction with devices through study specific questionnaires.
Time frame: At the end of Period 1 (Group A), at the end of Period 2 (Group B) (each period is 6 weeks)
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