Impact of Patient Controlled Positive End-expiratory Pressure on Speech in Tracheostomized Ventilated Patients (OptiPEP)

This study has been completed.
Sponsor:
Collaborator:
Adep Assistance
Information provided by (Responsible Party):
PRIGENT, University of Versailles
ClinicalTrials.gov Identifier:
NCT01479959
First received: November 17, 2011
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

Adequate communication is a major part of the quality of life of tracheostomized ventilator dependent patients. Maintaining speech is therefore major goal in the management of these patients.

The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the improvement of speech. The best level for speech may vary from one patient to the other The purpose of this study is to determine individually the most efficient PEEP level in terms of speech while obtaining the most secure condition and the best possible respiratory tolerance. In order to improve the latter, the investigators will use a device which allows the patients to control the activation of PEEP so that they can use it only when needed (i.e. when they wish to speak). The investigators will compare the effect of different PEEP level to try to determine the best compromise to improve speech in tracheostomized ventilator-dependent patients.


Condition Intervention
Chronic Respiratory Failure
Device: Eole 3 ventilator - Resmed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of Optimal PEEP Level Under Patient Control in Tracheostomized Ventilated Patients

Resource links provided by NLM:


Further study details as provided by University of Versailles:

Primary Outcome Measures:
  • Efficiency of PEEP level on speech [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Measurement of the duration of a text passage reading, the maximal phonation time throughout the repsiratory cycle.


Secondary Outcome Measures:
  • Effect of PEEP level on voice quality [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Subjective evaluation by the patients with a visual analogic scale. Objective evaluation by two speech therapists (blinded to speech condition)assessing intelligibility, perceptual quality and prosody

  • Respiratory Comfort evaluated with a visual analogic scale by patients [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • Respiratory tolerance [ Time Frame: 20 minute ] [ Designated as safety issue: No ]
    Evaluation of respiratory tolerance through measurements of oxygen saturation , heart rate and respiratory rate

  • Use of PEEP control switch [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    number of use of the PEEP control switch during the text passage reading


Enrollment: 14
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No PEEP level
protocol conducted while no PEEP is applied
Device: Eole 3 ventilator - Resmed
positive end expiratory pressure is added to the ventilation mode and it is activated by a switch under patient's control
Other Name: Goodnight 420E, Tyco Healthcare, Puritan Bennett
Active Comparator: effective PEEP level (PEEPeff)
PEEP level allowing the entire expiratory volume to go through the upper airways during quiet breathing
Device: Eole 3 ventilator - Resmed
positive end expiratory pressure is added to the ventilation mode and it is activated by a switch under patient's control
Other Name: Goodnight 420E, Tyco Healthcare, Puritan Bennett
Active Comparator: intermediate PEEP level (PEEP50)
50% of PEEPeff
Device: Eole 3 ventilator - Resmed
positive end expiratory pressure is added to the ventilation mode and it is activated by a switch under patient's control
Other Name: Goodnight 420E, Tyco Healthcare, Puritan Bennett

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient
  • Stable state upon inclusion
  • Neuromuscular patients, tracheostomized and on long term ventilation with a cuffless tube
  • Assist control volumetric ventilation mode
  • Signed consent form

Exclusion Criteria:

  • Pregnancy
  • Patients unable to read
  • Acute respiratory failure
  • Contra-indication of PEEP use
  • Lack of social security coverage
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479959

Locations
France
Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
Adep Assistance
Investigators
Principal Investigator: Helene PRIGENT, MD Hôpital Raymond Poincaré - APHP
Study Director: Frederic LOFASO, MD-PhD University of Versailles
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PRIGENT, Dr Helene PRIGENT MD, University of Versailles
ClinicalTrials.gov Identifier: NCT01479959     History of Changes
Other Study ID Numbers: Optipep -10-007
Study First Received: November 17, 2011
Last Updated: November 22, 2011
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by University of Versailles:
Tracheostomy
positive end expiratory pressure
speech
respiratory failure
ventilation
neuromuscular disorders

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014