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

NCT01976819 | Completed Results

• 1 other identifier: UD788_TW
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy

Keywords

Tracheotomy; Tracheostomy; Speaking valve; HME; patients

Outcome Measures

Primary Outcomes (3)

• 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.

  Patients were asked to use either the old TW15 and the TW22 HME device for a week, data combined for the two devices (the device used was recorded). After each week, patients completed a device specific questionnaire (Borg Scale). After the re-design (ie Updated speaking valve), patients were asked to use the new Speaking Valve for a week and then to complete relevant sections of the same questionnaire. Both at baseline and in the follow-up, patients were asked about their breathing using a Borg scale at a particular moment. This scale has a range from 0-6 where a score close to "0" indicates less breathing problems.

  3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).

• Hours of HME Use Per Day.

  The mean number of hours of TW use per 24 hours was calculated.

  Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)

• Device Preference Rating.

  Patients were asked to rate the devices on a scale from 0-10, where "10" indicates the best score and "0" the worst score. The overall mean satisfaction with the speaking valve was rated.

  Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)

Study Arms (1)

TW speaking valve/HME

EXPERIMENTAL

Use of the TW speaking valve/HME

Device: TW speaking valve/HME

Interventions

TW speaking valve/HME 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.

Also known as: DualCare speaking valve/HME

TW speaking valve/HME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atos Medical AB: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Limitations and Caveats

small sample size;

Results Point of Contact

• Title: Prof. Dr. Bernard F.A.M. van der Laan, PhD, MD
• Organization: University Medical Center Groningen and University of Groningen

b.f.a.m.van.der.laan@umcg.nl

0031 (50) 361 27 00

Study Officials

• Bernardus FA van der Laan, PhD, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: November 6, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 11, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)