Clinical trial NCT01976819: Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients
Official title: Phase 2 Clinical Feasibility Study of a New Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy
Keywords: Tracheotomy
Tracheostomy
Speaking valve
HME
patients
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical investigation addresses the performance of a re-designed The current study aims to investigate the next version of the TW speaking valve, in combination with both a 15mm and 22mm HME cassette.

Detailed description: This clinical investigation addresses the performance of a re-designed (updated) speaking valve with Heat and Moisture Exchangers (HME) for tracheotomized patients (project development name 'TW', commercial name 'DualCare'). Study participants trial the new device for 2 weeks after which they can choose to discontinue using the device or continue in the 3 month follow-up part of the study. Clinical feasibility is assessed using structured questionnaires addressing voice and speech, quality of life, breathing, swallowing, olfaction, sleeping, and respiratory symptoms. This is an exploratory, observational study and no specific hypotheses have been formulated.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* has a tracheostomy
* is spontaneously breathing
* has a cuffless tracheostomy tube
* has a tracheostomy tube with inner and outer cannula
* currently uses an HME and/or speaking valve

Exclusion Criteria:

* patient unable to handle or remove the device him/herself when needed, e.g. has decreased level of cognition or reduced mobility of the arms and/or hands
* is mechanically ventilated in any way
* has a tidal volume of less than 100 ml
* is suffering from severe aspiration
* is laryngectomized: the device will block the possibility to exhale if speaking mode is unintentionally activated
* has severe upper airway obstruction, this may cause air trapping
* has thick and copious secretions which might block the device

Primary outcomes:
measure: Evaluate Patient Experiences Associated With Exposure to the Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients Based on Results From Questionnaires.
timeFrame: 3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).
measure: Hours of HME Use Per Day.
timeFrame: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)
measure: Device Preference Rating.
timeFrame: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Bernardus FA van der Laan, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: