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

NCT00978783 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2009-09-17

No results posted yet for this study

Summary

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.

Conditions

  • Tracheostomy
  • Mechanical Ventilation

Interventions

DEVICE

Passy Muir Valve

The Passy Muir Valve was fixed on the tracheostomy tube

DEVICE

Positive end expiratory pressure

5 cm H2O PEEP was adjusted

Sponsors & Collaborators

  • University of Versailles

    lead OTHER

Principal Investigators

  • Djillali Annane, MD, PhD · CIC-IT, R. Poincaré Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978783 on ClinicalTrials.gov