Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients

NCT ID: NCT01976819

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-04-30

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.

Conditions

Tracheostomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TW speaking valve/HME

Use of the TW speaking valve/HME

Group Type: EXPERIMENTAL

TW speaking valve/HME

Intervention Type: DEVICE

The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and TW22 will be combined.

Interventions

TW speaking valve/HME

The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and TW22 will be combined.

Intervention Type: DEVICE

Other Intervention Names

DualCare speaking valve/HME

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atos Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernardus FA van der Laan, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

UD788_TW

Identifier Type: -

Identifier Source: org_study_id