Chronic Respiratory Failure Clinical Trial
— OptiPEPOfficial 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.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hopital Raymond Poincare | Garches |
Lead Sponsor | Collaborator |
---|---|
University of Versailles | Adep Assistance |
France,
Bach JR, Alba AS. Tracheostomy ventilation. A study of efficacy with deflated cuffs and cuffless tubes. Chest. 1990 Mar;97(3):679-83. — View Citation
Hoit JD, Banzett RB, Lohmeier HL, Hixon TJ, Brown R. Clinical ventilator adjustments that improve speech. Chest. 2003 Oct;124(4):1512-21. — View Citation
Hoit JD, Shea SA, Banzett RB. Speech production during mechanical ventilation in tracheostomized individuals. J Speech Hear Res. 1994 Feb;37(1):53-63. — View Citation
Pellegrini N, Pelletier A, Orlikowski D, Lolierou C, Ruquet M, Raphaël JC, Lofaso F. Hand versus mouth for call-bell activation by DMD and Becker patients. Neuromuscul Disord. 2007 Jul;17(7):532-6. Epub 2007 May 29. — View Citation
Prigent H, Garguilo M, Pascal S, Pouplin S, Bouteille J, Lejaille M, Orlikowski D, Lofaso F. Speech effects of a speaking valve versus external PEEP in tracheostomized ventilator-dependent neuromuscular patients. Intensive Care Med. 2010 Oct;36(10):1681-7. doi: 10.1007/s00134-010-1935-0. Epub 2010 Jun 10. — View Citation
Prigent H, Samuel C, Louis B, Abinun MF, Zerah-Lancner F, Lejaille M, Raphael JC, Lofaso F. Comparative effects of two ventilatory modes on speech in tracheostomized patients with neuromuscular disease. Am J Respir Crit Care Med. 2003 Jan 15;167(2):114-9. Epub 2002 Oct 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficiency of PEEP level on speech | Measurement of the duration of a text passage reading, the maximal phonation time throughout the repsiratory cycle. | 20 minutes | No |
Secondary | Effect of PEEP level on voice quality | 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 | 20 minutes | No |
Secondary | Respiratory Comfort evaluated with a visual analogic scale by patients | 20 minutes | No | |
Secondary | Respiratory tolerance | Evaluation of respiratory tolerance through measurements of oxygen saturation , heart rate and respiratory rate | 20 minute | No |
Secondary | Use of PEEP control switch | number of use of the PEEP control switch during the text passage reading | 20 minutes | No |
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