Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy
Phase 1
Completed
- Conditions
- Total Laryngectomy
- Interventions
- Device: Provox Xtra HME
- Registration Number
- NCT00942903
- Lead Sponsor
- Atos Medical AB
- Brief Summary
This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- total laryngectomy
- compliant Provox HME user (24/7 use)
Exclusion Criteria
- current medical problems that might influence HME use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Compliant HME users Provox Xtra HME Laryngectomized patients who are currently compliant (24/7) users of a Provox HME
- Primary Outcome Measures
Name Time Method Patient Preference for Provox HME or Provox XtraHME 3 weeks the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.
- Secondary Outcome Measures
Name Time Method Noise at Stoma Occlusion 3 weeks the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME
Trial Locations
- Locations (1)
Netherlands Cancer Institute
🇳🇱Amsterdam, Noord Holland, Netherlands