{
  "FullStudy":{
    "Rank":218287,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510275",
          "OrgStudyIdInfo":{
            "OrgStudyId":"VP-02-2010"
          },
          "Organization":{
            "OrgFullName":"Villa Pineta Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Combined Use of Respiratory Devices After Thoracic Surgery",
          "OfficialTitle":"Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 25, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 26, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Prof. Clini Enrico",
            "ResponsiblePartyInvestigatorTitle":"Prof.",
            "ResponsiblePartyInvestigatorAffiliation":"Villa Pineta Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Villa Pineta Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"In a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. New devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent history of cardio-thoracic surgery."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Dyspnea",
              "Well Being"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "cardio-thoracic surgery",
              "patients",
              "pulmonary volume",
              "respiratory muscle performance"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"60",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Intervention",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Combined use of RESPIVOL® and RESPILIFT® (with resistive load)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Combined use of RESPIVOL® and RESPILIFT®"
                  ]
                }
              },{
                "ArmGroupLabel":"Control",
                "ArmGroupType":"Sham Comparator",
                "ArmGroupDescription":"Combined use of RESPIVOL® and RESPILIFT® (without resistive load)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Combined use of RESPIVOL® and RESPILIFT®"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Combined use of RESPIVOL® and RESPILIFT®",
                "InterventionDescription":"Active devices (combined) for 14 consecutive session, bid, for 15 minutes.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Intervention"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"Combined use of RESPIVOL® and RESPILIFT®",
                "InterventionDescription":"Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Respiratory muscle performance",
                "PrimaryOutcomeDescription":"Change of MEP (Maximum Expiratory Pressure)measure",
                "PrimaryOutcomeTimeFrame":"Change from Baseline in MEP at 6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Respiratory muscle performance",
                "SecondaryOutcomeDescription":"Change of MIP (Maximum Inspiratory Pressure)measure",
                "SecondaryOutcomeTimeFrame":"Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)"
              },{
                "SecondaryOutcomeMeasure":"Pulmonary volumes",
                "SecondaryOutcomeDescription":"Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV)",
                "SecondaryOutcomeTimeFrame":"Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)"
              },{
                "SecondaryOutcomeMeasure":"Pulmonary gas exchange",
                "SecondaryOutcomeDescription":"Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2",
                "SecondaryOutcomeTimeFrame":"Enrollment (T0), at the end (T14) and after 6 months (T6m)"
              },{
                "SecondaryOutcomeMeasure":"Perceived dispnoea, well being and thoracic pain",
                "SecondaryOutcomeDescription":"Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS)",
                "SecondaryOutcomeTimeFrame":"At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m)"
              },{
                "SecondaryOutcomeMeasure":"Perceived quality of life",
                "SecondaryOutcomeDescription":"Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version",
                "SecondaryOutcomeTimeFrame":"Enrollment (T0), at the end (T14) and after 6 months (T6m)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n> 18 years old\nrecent cardio-thoracic surgery (< 30 days of admission)\ncompliance to pulmonary rehabilitation program\n\nExclusion Criteria:\n\nclinical instability\nconcomitant severe co-morbidities\ninability to use respiratory devices",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"19 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Enrico E Clini, MD",
                "OverallOfficialAffiliation":"University of Modena - Ospedale Villa Pineta",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Villa Pineta Hospital",
                "LocationCity":"Modena",
                "LocationZip":"41026",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Villa Pineta Hospital",
                "LocationCity":"Modena",
                "LocationCountry":"Italy"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"23984352",
                "ReferenceType":"derived",
                "ReferenceCitation":"Crisafulli E, Venturelli E, Siscaro G, Florini F, Papetti A, Lugli D, Cerulli M, Clini E. Respiratory muscle training in patients recovering recent open cardiothoracic surgery: a randomized-controlled trial. Biomed Res Int. 2013;2013:354276. doi: 10.1155/2013/354276. Epub 2013 Jul 30."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000004417",
                "ConditionMeshTerm":"Dyspnea"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012120",
                "ConditionAncestorTerm":"Respiration Disorders"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000012818",
                "ConditionAncestorTerm":"Signs and Symptoms, Respiratory"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M6174",
                "ConditionBrowseLeafName":"Dyspnea",
                "ConditionBrowseLeafAsFound":"Dyspnea",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13540",
                "ConditionBrowseLeafName":"Respiration Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14206",
                "ConditionBrowseLeafName":"Signs and Symptoms, Respiratory",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}