{
  "FullStudy":{
    "Rank":218030,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513642",
          "OrgStudyIdInfo":{
            "OrgStudyId":"oliveira1"
          },
          "Organization":{
            "OrgFullName":"Universidade Federal do Rio de Janeiro",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Respiratory Physiotherapy After Cardiac Surgery",
          "OfficialTitle":"Inspiratory Volume and Muscle Recruitment During Breath-stacking and Incentive Spirometry Techniques in Postoperative Cardiac Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2010",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 20, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Juliana Flávia de Oliveira",
            "ResponsiblePartyInvestigatorTitle":"Inspiratory Volume and Muscle Recruitment During Breath-stacking and Incentive Spirometry Techniques in Postoperative Cardiac Patients.",
            "ResponsiblePartyInvestigatorAffiliation":"Universidade Federal do Rio de Janeiro"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Universidade Federal do Rio de Janeiro",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac surgery patients, the breath-stacking technique has been proposed as an alternative to increase pulmonary volumes in the post-operative period.\n\nObjective: To compare inspiratory volume and electromyographic activity of respiratory muscles during breath stacking technique and incentive spirometry in patients undergoing cardiac surgery.",
          "DetailedDescription":"The purpose of the present study are:\n\nto evaluate and compare the inspiratory volume during the course of Breath Stacking and Incentive Spirometry techniques in patients submitted to myocardial revascularization surgery.\nto compare the electromyographic activity of the scalene, sternocleidomastoid (SCM) and diaphragm muscles during both techniques."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Functional Disturbance Following Cardiac Surgery"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "physiotherapy",
              "cardiac surgery",
              "breath Stacking"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"16",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Incentive spirometry",
                "ArmGroupType":"Other",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Breath Stacking"
                  ]
                }
              },{
                "ArmGroupLabel":"Breath Stacking",
                "ArmGroupType":"No Intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Breath Stacking",
                "InterventionDescription":"To perform the BS maneuver, a silicone mask containing a one-way valve was attached to the patient's face. Once the mask was adjusted to allow only inspiration (the expiratory branch remained occluded), the patient was asked to make successive inspiratory efforts during 20 seconds.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Incentive spirometry"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "respiratory exercises"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Inspiratory volume and muscle recruitment during breath-stacking and incentive spirometry techniques in postoperative cardiac patients",
                "PrimaryOutcomeTimeFrame":"Within 2 days after cardiac surgery"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\npatients submitted to myocardial revascularization surgery\n\nExclusion Criteria:\n\ncognitive impairment or incoordination to perform IS\nface mask intolerance during BS\nlevel of consciousness incompatible to perform IS\nhemodynamic complications [arrhythmia, intraoperative myocardial infarction, major blood loss (defined as a loss of ≥20% of total blood volume), mean arterial pressure <70 mmHg and reduce cardiac output requiring the use of an intra-aortic balloon pump or vasoactive drugs)\nintubation for more than 72 h after admission to the Intensive Care Unit\nthe need for reintubation.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"50 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Cristina Dias, PhD",
                "OverallOfficialAffiliation":"Centro Universitário Augusto Motta",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Federal Bonsucesso Hospital",
                "LocationCity":"Rio de Janeiro",
                "LocationZip":"21041030",
                "LocationCountry":"Brazil"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M25724",
                "ConditionBrowseLeafName":"Respiratory Aspiration",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}