Total Laryngectomy
Conditions
Keywords
HME, Provox, voice prosthesis, laryngectomy
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.
Interventions
DEVICEProvox Xtra HME
Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy
Sponsors
The Netherlands Cancer Institute
Atos Medical AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* total laryngectomy * compliant Provox HME user (24/7 use)
Exclusion criteria
* current medical problems that might influence HME use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Provox XtraHME A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Provox XtraHME |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 66.4 years STANDARD_DEVIATION 9.07 |
| Region of Enrollment Netherlands | 20 patients |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Patient Preference for Provox HME or Provox XtraHME
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.
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provox XtraHME | Patient Preference for Provox HME or Provox XtraHME | Preference new Provox XtraHME | 12 Patients |
| Provox XtraHME | Patient Preference for Provox HME or Provox XtraHME | Preference 'old' Provox HME | 3 Patients |
| Provox XtraHME | Patient Preference for Provox HME or Provox XtraHME | No preference | 5 Patients |
Secondary
Noise at Stoma Occlusion
the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Provox XtraHME | Noise at Stoma Occlusion | No noise at stoma occlusion | 20 patients |
| Provox XtraHME | Noise at Stoma Occlusion | Noise at stoma occlusion | 0 patients |