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Speech Effects of a Speaking Valve Versus External Positive End-expiratory Pressure (PEEP) in Tracheostomized Ventilator-Dependent Neuromuscular Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978783
First Posted: September 17, 2009
Last Update Posted: September 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Versailles
  Purpose

Background:

Many patients with respiratory failure related to neuromuscular disease receive chronic invasive ventilation through a tracheostomy. Improving quality of life, of which speech is an important component, is a major goal in these patients. The investigators compared the effects on breathing and speech of low-level positive end-expiratory pressure (PEEP, 5 cm H2O) and of a Passy-Muir speaking valve (PMV) during assist-control ventilation.

Methods:

Flow will be measured using a pneumotachograph. Microphone speech recordings were subjected to both quantitative measurements and qualitative assessments; these last consisted of a perceptual score and an intelligibility score determined by two speech therapists using a French adaptation of the Frenchay Dysarthria Assessment.


Condition Intervention Phase
Tracheostomy Mechanical Ventilation Device: Passy Muir Valve Device: Positive end expiratory pressure Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Speech Effects of a Speaking Valve Versus External PEEP in Tracheostomized Ventilator-Dependent Neuromuscular Patients

Further study details as provided by University of Versailles:

Primary Outcome Measures:
  • text reading duration [ Time Frame: 1 hour ]

Secondary Outcome Measures:
  • respiratory comfort [ Time Frame: 1 hour ]
  • speech comfort [ Time Frame: 2 hours ]
  • Dragon NaturallySpeaking 10® system ability to recognise the speech [ Time Frame: 30 minutes ]
  • Sustained [a] duration [ Time Frame: 15 minutes ]
  • perceptual score and intelligibility score determined by 2 blinded speech therapists [ Time Frame: 2 hours ]

Enrollment: 10
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: speaking valve Device: Passy Muir Valve
The Passy Muir Valve was fixed on the tracheostomy tube
Other Name: phonation valve
Active Comparator: Positive end expiratory pressure Device: Positive end expiratory pressure
5 cm H2O PEEP was adjusted
Other Name: PEEP

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neuromuscular patients
  • Patients received mechanical ventilation via a cuffless tracheostomy

Exclusion Criteria:

  • Acute respiratory failure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978783


Locations
France
Intensive care Ward of R. Poincaré Hospital
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
Investigators
Study Chair: Djillali Annane, MD, PhD CIC-IT, R. Poincaré Hospital
  More Information

Responsible Party: Lofaso Frédéric, MD,PhD, Head of the Physiological Ward, R. Poincaré Hospital
ClinicalTrials.gov Identifier: NCT00978783     History of Changes
Other Study ID Numbers: PMV vs PEEP
First Submitted: September 8, 2009
First Posted: September 17, 2009
Last Update Posted: September 17, 2009
Last Verified: September 2009

Keywords provided by University of Versailles:
Phonation
Tracheostomy
phonation valve
positive end expiratory pressure