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:
Information provided by:
University of Versailles
ClinicalTrials.gov Identifier:
NCT00978783
First received: September 8, 2009
Last updated: September 16, 2009
Last verified: September 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • respiratory comfort [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
  • speech comfort [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
  • Dragon NaturallySpeaking 10® system ability to recognise the speech [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Sustained [a] duration [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • perceptual score and intelligibility score determined by 2 blinded speech therapists [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 8, 2009
Last Updated: September 16, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 23, 2014