Chronic Respiratory Failure Clinical Trial
Official title:
Determination of Optimal PEEP Level Under Patient Control in Tracheostomized Ventilated Patients
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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