{
  "FullStudy":{
    "Rank":217692,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518075",
          "OrgStudyIdInfo":{
            "OrgStudyId":"DEGLUT"
          },
          "Organization":{
            "OrgFullName":"University Hospital, Caen",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Breathing-swallowing Interaction in Chronic Obstructive Pulmonary Disease Patients - Impact of Non Invasive Ventilation",
          "OfficialTitle":"Breathing-swallowing Interaction in Chronic Obstructive Pulmonary Disease (COPD) Patients Hospitalized in Intensive Care Unit for an Acute Exacerbation: Impact of Non Invasive Ventilation. Physiological Evaluation"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 21, 2012",
          "StudyFirstSubmitQCDate":"January 21, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 14, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 17, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Hospital, Caen",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"In the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction.\n\nOur main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)",
          "DetailedDescription":"In healthy subjects previous studies showed that most swallows started during expiration and were followed by expiration, a pattern believed to contribute to airway protection during swallowing. However In healthy individuals, the occurrence of inspiration after swallows was increased by hypercapnia or application of an inspiratory elastic load.\n\nIn a previous study the investigators have demonstrated that patients with neuromuscular disorders exhibited piecemeal deglutition leading to an increase in the time needed to swallow a water bolus, as well as occurrence of inspiration after nearly half the swallows. These abnormalities which increased with the decreasing of respiratory muscle performances may explain feeding difficulties. However in tracheostomized patients who could breathe spontaneously, piecemeal deglutition and swallowing time per bolus were diminished by the use of mechanical ventilation.\n\nIn the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction.\n\nThe investigators' main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Chronic Obstructive Pulmonary Disease (COPD)",
              "Decompensated COPD With (Acute) Exacerbation"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Chronic Obstructive Pulmonary Disease",
              "Non invasive mechanical ventilation",
              "Breathing-swallowing interaction",
              "Intensive Care Unit"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"16",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Non invasive mechanical ventilation",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Evaluation of breathing swallowing interaction under non invasive mechanical ventilation",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Non Invasive Mechanical Ventilation"
                  ]
                }
              },{
                "ArmGroupLabel":"Spontaneous Breathing",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Evaluation of breathing swallowing interaction without non invasive mechanical ventilation",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Spontaneous Breathing"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Spontaneous Breathing",
                "InterventionDescription":"Evaluation of breathing - swallowing interaction without non invasive mechanical ventilation. Patient breath spontaneously.\n\nMeasurements of respiratory and swallowing parameters were monitored using respiratory inductive plethysmography. Swallowing was monitored noninvasively. Two bolus sizes were used, (5, 10 ml), in random order. Five sets of two boluses were studied, taking care not to use the same bolus size twice consecutively. The study participants were blinded to bolus size.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Spontaneous Breathing"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "SB"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Non Invasive Mechanical Ventilation",
                "InterventionDescription":"Evaluation of breathing - swallowing interaction with non invasive mechanical ventilation. Patient breath under non invasive mechanical ventilation. Measurements of respiratory and swallowing parameters were monitored using respiratory inductive plethysmography. Swallowing was monitored noninvasively. Two bolus sizes were used, (5, 10 ml), in random order. Five sets of two boluses were studied, taking care not to use the same bolus size twice consecutively. The study participants were blinded to bolus size.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Non invasive mechanical ventilation"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "NIV"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Impact of non invasive mechanical ventilation on breathing swallowing interaction",
                "PrimaryOutcomeDescription":"Physiological evaluation of breathing - swallowing interaction with or without non invasive mechanical ventilation",
                "PrimaryOutcomeTimeFrame":"2 h"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Correlation between breathing swallowing interaction and functional respiratory parameters",
                "SecondaryOutcomeTimeFrame":"24 h"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with Chronic Obstructive Pulmonary Disease\nAge > 18 years\nHospitalized in Intensive care for an acute exacerbation\nRequiring Non invasive mechanical ventilation\nAble to breath spontaneously without non invasive ventilation more than 4h/day\nWithout bulbar dysfunction\n\nExclusion Criteria:\n\nHemodynamic instability\nAbsence of consent\nSevere Hypoxemia\npH < 7,30\nNo cooperation of the patient",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Nicolas TERZI, MD - PhD",
                "OverallOfficialAffiliation":"University Hospital, Caen",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Frédéric Lofaso, MD-PhD",
                "OverallOfficialAffiliation":"University Hospital, Garches",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University Hospital, Caen",
                "LocationCity":"Caen",
                "LocationZip":"14000",
                "LocationCountry":"France"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000029424",
                "ConditionMeshTerm":"Pulmonary Disease, Chronic Obstructive"
              },{
                "ConditionMeshId":"D000008171",
                "ConditionMeshTerm":"Lung Diseases"
              },{
                "ConditionMeshId":"D000008173",
                "ConditionMeshTerm":"Lung Diseases, Obstructive"
              },{
                "ConditionMeshId":"D000053120",
                "ConditionMeshTerm":"Respiratory Aspiration"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000012120",
                "ConditionAncestorTerm":"Respiration Disorders"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M25724",
                "ConditionBrowseLeafName":"Respiratory Aspiration",
                "ConditionBrowseLeafAsFound":"Breathing",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9751",
                "ConditionBrowseLeafName":"Lung Diseases",
                "ConditionBrowseLeafAsFound":"Pulmonary Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9753",
                "ConditionBrowseLeafName":"Lung Diseases, Obstructive",
                "ConditionBrowseLeafAsFound":"Obstructive Pulmonary Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M22033",
                "ConditionBrowseLeafName":"Pulmonary Disease, Chronic Obstructive",
                "ConditionBrowseLeafAsFound":"Chronic Obstructive Pulmonary Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13540",
                "ConditionBrowseLeafName":"Respiration Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}