Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy

Atos Medical AB20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Total Laryngectomy

Interventions

Provox Xtra HMEDEVICE

Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * total laryngectomy * compliant Provox HME user (24/7 use) Exclusion Criteria: * current medical problems that might influence HME use

Locations (1)

Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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