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

NCT01479959 | Completed

• 1 other identifier: Optipep -10-007
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Respiratory Failure

Keywords

Tracheostomy; positive end expiratory pressure; speech; respiratory failure; ventilation; neuromuscular disorders

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Effect of PEEP level on voice quality

  20 minutes

• Respiratory Comfort evaluated with a visual analogic scale by patients

  20 minutes

• Respiratory tolerance

  20 minute

• Use of PEEP control switch

  20 minutes

Study Arms (3)

No PEEP level

ACTIVE COMPARATOR

protocol conducted while no PEEP is applied

Device: Eole 3 ventilator - Resmed

effective PEEP level (PEEPeff)

ACTIVE COMPARATOR

PEEP level allowing the entire expiratory volume to go through the upper airways during quiet breathing

Device: Eole 3 ventilator - Resmed

intermediate PEEP level (PEEP50)

ACTIVE COMPARATOR

50% of PEEPeff

Device: Eole 3 ventilator - Resmed

Interventions

Eole 3 ventilator - Resmed DEVICE

positive end expiratory pressure is added to the ventilation mode and it is activated by a switch under patient's control

Also known as: Goodnight 420E, Tyco Healthcare, Puritan Bennett

No PEEP level; effective PEEP level (PEEPeff); intermediate PEEP level (PEEP50)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Patients unable to read
• Acute respiratory failure
• Contra-indication of PEEP use
• Lack of social security coverage

Sponsors & Collaborators

• University of Versailles: lead
• Adep Assistance: collaborator

Study Sites (1)

Hopital Raymond Poincare

Garches, 92380, France

Location

Related Publications (7)

• 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. doi: 10.1164/rccm.200201-026OC. Epub 2002 Oct 4.

  PMID: 12406841 BACKGROUND

• 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):1681-1687. doi: 10.1007/s00134-010-1935-0. Epub 2010 Jun 10.

  PMID: 20535605 BACKGROUND

• Pellegrini N, Pelletier A, Orlikowski D, Lolierou C, Ruquet M, Raphael JC, Lofaso F. Hand versus mouth for call-bell activation by DMD and Becker patients. Neuromuscul Disord. 2007 Jul;17(7):532-6. doi: 10.1016/j.nmd.2007.03.016. Epub 2007 May 29.

  PMID: 17533130 BACKGROUND

• Bach JR, Alba AS. Tracheostomy ventilation. A study of efficacy with deflated cuffs and cuffless tubes. Chest. 1990 Mar;97(3):679-83. doi: 10.1378/chest.97.3.679.

  PMID: 2407453 BACKGROUND

• Hoit JD, Banzett RB, Lohmeier HL, Hixon TJ, Brown R. Clinical ventilator adjustments that improve speech. Chest. 2003 Oct;124(4):1512-21. doi: 10.1378/chest.124.4.1512.

  PMID: 14555587 BACKGROUND

• Hoit JD, Shea SA, Banzett RB. Speech production during mechanical ventilation in tracheostomized individuals. J Speech Hear Res. 1994 Feb;37(1):53-63. doi: 10.1044/jshr.3701.53.

  PMID: 8170131 BACKGROUND

• Garguilo M, Leroux K, Lejaille M, Pascal S, Orlikowski D, Lofaso F, Prigent H. Patient-controlled positive end-expiratory pressure with neuromuscular disease: effect on speech in patients with tracheostomy and mechanical ventilation support. Chest. 2013 May;143(5):1243-1251. doi: 10.1378/chest.12-0574.

  PMID: 23715608 DERIVED

MeSH Terms

Conditions

Speech; Respiratory Insufficiency; Respiratory Aspiration; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Verbal Behavior; Communication; Behavior; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Helene PRIGENT, MD

  Hôpital Raymond Poincaré - APHP

  PRINCIPAL INVESTIGATOR

• Frederic LOFASO, MD-PhD

  University of Versailles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Helene PRIGENT MD

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 28, 2011
• Study Start: June 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 28, 2011

Record last verified: 2011-11

Locations

FR (1)