Phase 1
Completed N=20
Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy
Total Laryngectomy
Source: ClinicalTrials.gov NCT00942903 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Patient Preference for Provox HME or Provox XtraHME — 12; 3; 5 Patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Preference for Provox HME or Provox XtraHME |
12; 3; 5 | — |
| SECONDARY Noise at Stoma Occlusion |
20; 0 | — |
Eligibility Criteria
Inclusion Criteria
- total laryngectomy
- compliant Provox HME user (24/7 use)
Exclusion Criteria
- current medical problems that might influence HME use
Data sourced from ClinicalTrials.gov (NCT00942903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.