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| Name | Class |
|---|---|
| The Netherlands Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compliant HME users | Experimental | Laryngectomized patients who are currently compliant (24/7) users of a Provox HME |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provox Xtra HME | Device | Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frans JM Hilgers, MD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | North Holland | 1066 CX | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Provox XtraHME | A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Provox XtraHME | A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Patients | 3 weeks |
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Adverse events were monitored during the three weeks of the study
Adverse events were assessed during the three weeks the patients used the HME's, upon notification of a problem by the patient, and when the patient returned for a visit. When patients start using a new type of HME, they may need to adjust and may perceive an increased breathing resistance. This was not considered an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Provox XtraHME | A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. F.J.M. Hilgers | The Netherlands Cancer Institute | +31-20-5122550 | f.hilgers@nki.nl |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | patients |
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| 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 | Posted | Number | patients | 3 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
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