Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-01 @ 7:41 AM
Study NCT ID:
NCT01479959
Status:
COMPLETED
Last Update Posted:
2011-11-28
First Post:
2011-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Patient Controlled Positive End-expiratory Pressure on Speech in Tracheostomized Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013060', 'term': 'Speech'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-11-22', 'lastUpdatePostDateStruct': {'date': '2011-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficiency of PEEP level on speech', 'timeFrame': '20 minutes', 'description': 'Measurement of the duration of a text passage reading, the maximal phonation time throughout the repsiratory cycle.'}], 'secondaryOutcomes': [{'measure': 'Effect of PEEP level on voice quality', 'timeFrame': '20 minutes', 'description': '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'}, {'measure': 'Respiratory Comfort evaluated with a visual analogic scale by patients', 'timeFrame': '20 minutes'}, {'measure': 'Respiratory tolerance', 'timeFrame': '20 minute', 'description': 'Evaluation of respiratory tolerance through measurements of oxygen saturation , heart rate and respiratory rate'}, {'measure': 'Use of PEEP control switch', 'timeFrame': '20 minutes', 'description': 'number of use of the PEEP control switch during the text passage reading'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tracheostomy', 'positive end expiratory pressure', 'speech', 'respiratory failure', 'ventilation', 'neuromuscular disorders'], 'conditions': ['Chronic Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '12406841', 'type': 'BACKGROUND', '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. doi: 10.1164/rccm.200201-026OC. Epub 2002 Oct 4.'}, {'pmid': '20535605', 'type': 'BACKGROUND', '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):1681-1687. doi: 10.1007/s00134-010-1935-0. Epub 2010 Jun 10.'}, {'pmid': '17533130', 'type': 'BACKGROUND', 'citation': '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': '2407453', 'type': 'BACKGROUND', 'citation': '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': '14555587', 'type': 'BACKGROUND', 'citation': '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': '8170131', 'type': 'BACKGROUND', '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. doi: 10.1044/jshr.3701.53.'}, {'pmid': '23715608', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': 'Context :\n\nAllowing a functional communication is a major issue in order to preserve quality of life in tracheostomized ventilator-dependent patients.\n\nWe 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).\n\nOptimal 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.\n\nIn 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).\n\nObjective :\n\nThe 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.\n\nMethods:\n\nOpen randomized monocentric cross-over study (the patients are their own control).\n\nOptimal 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.\n\nFor 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).\n\nSubjective 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.\n\nInclusion criteria:\n\nNeuromuscular 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.\n\nNumber of patients, center:\n\nConsidering 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.\n\nDuration of study: 12 months. Duration of participation for each patient will be 1h30.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Stable state upon inclusion\n* Neuromuscular patients, tracheostomized and on long term ventilation with a cuffless tube\n* Assist control volumetric ventilation mode\n* Signed consent form\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients unable to read\n* Acute respiratory failure\n* Contra-indication of PEEP use\n* Lack of social security coverage'}, 'identificationModule': {'nctId': 'NCT01479959', 'acronym': 'OptiPEP', 'briefTitle': 'Impact of Patient Controlled Positive End-expiratory Pressure on Speech in Tracheostomized Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Versailles'}, 'officialTitle': 'Determination of Optimal PEEP Level Under Patient Control in Tracheostomized Ventilated Patients', 'orgStudyIdInfo': {'id': 'Optipep -10-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No PEEP level', 'description': 'protocol conducted while no PEEP is applied', 'interventionNames': ['Device: Eole 3 ventilator - Resmed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'effective PEEP level (PEEPeff)', 'description': 'PEEP level allowing the entire expiratory volume to go through the upper airways during quiet breathing', 'interventionNames': ['Device: Eole 3 ventilator - Resmed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intermediate PEEP level (PEEP50)', 'description': '50% of PEEPeff', 'interventionNames': ['Device: Eole 3 ventilator - Resmed']}], 'interventions': [{'name': 'Eole 3 ventilator - Resmed', 'type': 'DEVICE', 'otherNames': ['Goodnight 420E, Tyco Healthcare, Puritan Bennett'], 'description': "positive end expiratory pressure is added to the ventilation mode and it is activated by a switch under patient's control", 'armGroupLabels': ['No PEEP level', 'effective PEEP level (PEEPeff)', 'intermediate PEEP level (PEEP50)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Helene PRIGENT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Raymond Poincaré - APHP'}, {'name': 'Frederic LOFASO, MD-PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Versailles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Versailles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Adep Assistance', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Helene PRIGENT MD', 'investigatorFullName': 'PRIGENT', 'investigatorAffiliation': 'University of Versailles'}}}}