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

  Hide Detailed Description

Detailed Description:

Context :

Allowing a functional communication is a major issue in order to preserve quality of life in tracheostomized ventilator-dependent patients.

We showed in a previous study that the use of a positive end-expiratory pressure (PEEP) in neuromuscular tracheostomized ventilator-dependent patients improved speech as it allows the patient to expire (at least partly) through the upper airways therefore to speak during expiration. The use of PEEP has been compared to the use of a phonation valve placed on the ventilator circuit which allows a complete expiration through the upper airways and therefore speech. Both techniques seem similar in terms of efficiency on speech; PEEP, however, is better tolerated and seems to be more secure (the system remains open during expiration decreasing the risk of high pressure, it does not require any handling of the ventilator circuit).

Optimal PEEP level allowing the patient to expire the total expiratory volume through the upper airways PEEPeff may vary from one patient to the other. We seek to determine individual PEEPeff and to compare it to 50% of its value (PEEPef50). Indeed, while PEEPeff may constitute the best level for expiratory speech as it mimics the mechanisms of a phonation valve without some of its fallbacks, by preventing expiration through the expiratory circuit of the ventilator, it also may lengthen expiration, delaying inspiration which allows speech, and facilitate hyperinflation leading to respiratory discomfort as we have previously observed with some patients using a phonation valve. Optimal PEEP level would be the best compromise between best possible phonation and best possible respiratory comfort and therefore could be lower than PEEPeff.

In order to improve respiratory comfort with higher PEEP level, we developed a prototype ventilator in which PEEP is activated by a switch under the control of patients who may activate it only when needed (during speech period).

Objective :

The main objective of the study is to optimize PEEP use both by determining individually its most appropriate level and by evaluation its use overtime to allow the best possible speech with the best respiratory comfort and the most secure condition for tracheostomized ventilated patients. Different PEEP levels will be evaluated and PEEP activation will be controlled by the patients.

Methods:

Open randomized monocentric cross-over study (the patients are their own control).

Optimal PEEP level (PEEPeff), defined as PEEP-level allowing complete expiration through the upper airways, will be determined for each patient. Speech and respiratory parameters were studied without PEEP, with PEEPeff and an intermediate PEEP-level(PEEP50). Flow and airway pressure will be measure and upper airways resistance will be calculated. Microphone speech recordings were subjected to both quantitative measurements and qualitative assessments of speech.

For each PEEP level the following protocol will be conducted: 5 minutes of quiet breathing with PEEP, 10 minutes spontaneous conversation, then speech trial(maximal sustained sound, glissando, text reading).

Subjective evaluation of speech and respiratory comfort(by the patient) and objective evaluation of speech improvement according to PEEP level (reading duration, phonation duration, voice quality, assessments of speech including an intelligibility score, a perceptual score and an evaluation of prosody analyzed by two experimented speech therapists blinded to PEEP level). Evaluation of the PEEP control button use by the patient.

Inclusion criteria:

Neuromuscular adult patients, tracheotomized and on long-term ventilation with a cuffless tube, on assist-control volumetric ventilation, in stable state at the time of the study.

Number of patients, center:

Considering it is a pilot study, 14 subjects will be included for the study. The subjects will be recruited in the home ventilation unit of the intensive care department of the R. Poincare teaching hospital (Garches, France) during their usual follow-up for their chronic respiratory failure.

Duration of study: 12 months. Duration of participation for each patient will be 1h30.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014