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

NCT00978783 | Completed Phase 2 DMC

• 1 other identifier: PMV vs PEEP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Phonation; Tracheostomy; phonation valve; positive end expiratory pressure

Outcome Measures

Primary Outcomes (1)

• text reading duration

  1 hour

Secondary Outcomes (5)

• respiratory comfort

  1 hour

• speech comfort

  2 hours

• Dragon NaturallySpeaking 10® system ability to recognise the speech

  30 minutes

• Sustained [a] duration

  15 minutes

• perceptual score and intelligibility score determined by 2 blinded speech therapists

  2 hours

Study Arms (2)

speaking valve

ACTIVE COMPARATOR

Device: Passy Muir Valve

Positive end expiratory pressure

ACTIVE COMPARATOR

Device: Positive end expiratory pressure

Interventions

Passy Muir Valve DEVICE

The Passy Muir Valve was fixed on the tracheostomy tube

Also known as: phonation valve

speaking valve

Positive end expiratory pressure DEVICE

5 cm H2O PEEP was adjusted

Also known as: PEEP

Positive end expiratory pressure

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Acute respiratory failure

Sponsors & Collaborators

• University of Versailles: lead

Study Sites (1)

Intensive care Ward of R. Poincaré Hospital

Garches, 92380, France

Location

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Djillali Annane, MD, PhD

  CIC-IT, R. Poincaré Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 17, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 17, 2009

Record last verified: 2009-09

Locations

FR (1)