{ "FullStudy":{ "Rank":217665, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518439", "OrgStudyIdInfo":{ "OrgStudyId":"2011-A00879-32" }, "Organization":{ "OrgFullName":"Centre d'Investigation Clinique et Technologique 805", "OrgClass":"OTHER" }, "BriefTitle":"Instrumental and Manual Increase of Couch in Neuromuscular Patients", "OfficialTitle":"Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow", "Acronym":"OPTICOUGH" }, "StatusModule":{ "StatusVerifiedDate":"July 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 18, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 19, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Centre d'Investigation Clinique et Technologique 805", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Adep Assistance", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Inefficient cough is responsible of respiratory complications in neuromuscular patients which can lead to hospitalisation and can be life threatening. Techniques enhancing cough efficiency are successful in improving the clearance of bronchial secretions and help non invasive ventilation efficiency especially in case of acute respiratory failure. Combining mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency. Therefore the investigators want to compare cough efficiency under different techniques of instrumental and manual of cough assistance in order to determine the best combination to optimize cough flow.", "DetailedDescription":"Hypothesis: Cough inefficiency in neuromuscular patients increases morbidity and mortality in case of airway infections and may lead to invasive ventilation. The use of techniques enhancing cough have been successful in improving the success of non invasive ventilation. We want to determine whether adding manual physiotherapist techniques to mechanical exsufflation improve cough efficiency and its ability to clear bronchial secretions.\n\nObjectives: To compare cough flows obtained with different combination of the use of increased inspiratory capacity technique, mechanical insufflation-exsufflation technique and manually applied pressures techniques.\n\nMethod:open monocentric cross-over study (the patients are their own controls). Five combinations of cough increase techniques are compared Inclusion criteria: adult neuromuscular patients with a cough inefficiency at a stable state upon inclusion.\n\nAs this is a pilot study, 20 patients from the home ventilation unit of the intensive care of the Raymond Poincare teaching hospital (Garches, France) will be included during the usual follow-up of chronic respiratory failure." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Neuromuscular Disease", "Chronic Respiratory Failure", "Coughing" ] }, "KeywordList":{ "Keyword":[ "neuromuscular", "cough", "restrictive" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"20", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"neuromuscular patients", "ArmGroupType":"Experimental", "ArmGroupDescription":"neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Alpha 200®", "Device: Alpha 200® + physiotherapist", "Device: Cough Assist®", "Device: Cough Assist® + physiotherapist", "Other: physiotherapist" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Alpha 200®", "InterventionDescription":"inspiratory capacity is increased with the use of constant pressure device: Alpha 200®", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "neuromuscular patients" ] } },{ "InterventionType":"Device", "InterventionName":"Alpha 200® + physiotherapist", "InterventionDescription":"inspiratory capacity is increased with the use of constant pressure device (Alpha 200®) combined with the manual pressures techniques to increase cough by the physiotherapist", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "neuromuscular patients" ] } },{ "InterventionType":"Device", "InterventionName":"Cough Assist®", "InterventionDescription":"increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "neuromuscular patients" ] } },{ "InterventionType":"Device", "InterventionName":"Cough Assist® + physiotherapist", "InterventionDescription":"increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®) combined with the manual pressures techniques to increase cough by the physiotherapist", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "neuromuscular patients" ] } },{ "InterventionType":"Other", "InterventionName":"physiotherapist", "InterventionDescription":"manual pressures techniques to increase cough applied by the physiotherapist", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "neuromuscular patients" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"cough flow obtained from the combination of mechanical and manual cough assistance techniques", "PrimaryOutcomeTimeFrame":"2 Hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"duration of efficient cough flow (above 180 l/min)under each cough assistance technique", "SecondaryOutcomeTimeFrame":"2 Hours" },{ "SecondaryOutcomeMeasure":"respiratory comfort", "SecondaryOutcomeDescription":"evaluation with a visual analogical scale", "SecondaryOutcomeTimeFrame":"2 Hours" },{ "SecondaryOutcomeMeasure":"subjective evaluation of cough efficiency", "SecondaryOutcomeDescription":"evaluation with a visual analogical scale", "SecondaryOutcomeTimeFrame":"2 Hours" },{ "SecondaryOutcomeMeasure":"Respiratory comfort", "SecondaryOutcomeDescription":"evaluation with the Borg dyspnea scale", "SecondaryOutcomeTimeFrame":"2 Hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nadult patients\nneuromuscular disorders with a respiratory restrictive syndrome (VC < 40% and/or cough flow < 180 L/min and/or Pe max < 40 cmH2O)\nnon invasive ventilation\nstable respiratory state > 1 month before inclusion\nsigned informed consent form\n\nExclusion Criteria:\n\nunstable respiratory state with increased bronchial secretions\nunstable hemodynamics\npneumothorax and or emphysema\ntracheostomy\nmajor bulbar involvement with swallowing dysfunction with the liquids\nPersons under Guardianship or Trusteeship\nPregnant women\nnot covered by the social security system\nrefusal of study participation", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Frederic Lofaso, Md-PhD", "OverallOfficialAffiliation":"University of Versailles", "OverallOfficialRole":"Study Director" },{ "OverallOfficialName":"Helene Prigent, MD-PhD", "OverallOfficialAffiliation":"University of Versailles", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"RAYMOND POINCARE Hospital", "LocationCity":"Garches", "LocationZip":"92380", "LocationCountry":"France" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000012131", "ConditionMeshTerm":"Respiratory Insufficiency" },{ "ConditionMeshId":"D000009468", "ConditionMeshTerm":"Neuromuscular Diseases" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012120", "ConditionAncestorTerm":"Respiration Disorders" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M13551", "ConditionBrowseLeafName":"Respiratory Insufficiency", "ConditionBrowseLeafAsFound":"Respiratory Failure", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5173", "ConditionBrowseLeafName":"Cough", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10994", "ConditionBrowseLeafName":"Neuromuscular Diseases", "ConditionBrowseLeafAsFound":"Neuromuscular Diseases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13102", "ConditionBrowseLeafName":"Pulmonary Valve Insufficiency", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13540", "ConditionBrowseLeafName":"Respiration Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" } ] } } } } } }