Assessment of the New Provox Life System for Pulmonary Health and Quality of Life After Total Laryngectomy
- Conditions
- Laryngectomy
- Interventions
- Device: Provox LifeDevice: Usual Care
- Registration Number
- NCT04974801
- Lead Sponsor
- Atos Medical AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual Care HMEs followed by Provox Life HMEs Provox Life Use of Usual Care devices during a period of six weeks followed by use of Provox Life devices during a period of six weeks. Usual Care HMEs followed by Provox Life HMEs Usual Care Use of Usual Care devices during a period of six weeks followed by use of Provox Life devices during a period of six weeks. Provox Life HMEs followed by Usual Care HMEs Provox Life Use of Provox Life devices during a period of six weeks followed by use of Usual Care devices during a period of six weeks. Provox Life HMEs followed by Usual Care HMEs Usual Care Use of Provox Life devices during a period of six weeks followed by use of Usual Care devices during a period of six weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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
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
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.
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
Trial Locations
- Locations (1)
Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'
🇮🇹Roma, Italy