Nctid:
NCT06224868
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002764", "term"=>"Cholecystitis"}], "ancestors"=>[{"id"=>"D000005705", "term"=>"Gallbladder Diseases"}, {"id"=>"D000001660", "term"=>"Biliary Tract Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M6005", "name"=>"Cholecystitis", "asFound"=>"Cholecystitis", "relevance"=>"HIGH"}, {"id"=>"M25019", "name"=>"Acalculous Cholecystitis", "relevance"=>"LOW"}, {"id"=>"M13917", "name"=>"Pneumoperitoneum", "relevance"=>"LOW"}, {"id"=>"M8823", "name"=>"Gallbladder Diseases", "relevance"=>"LOW"}, {"id"=>"M4946", "name"=>"Biliary Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T1150", "name"=>"Cholecystitis", "asFound"=>"Cholecystitis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"], "maskingDescription"=>"The anesthesiologist will not tell the radiologist making ultrasonography (USG) measurements which PEEP she set on the mechanical ventilator."}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Group 1: PEEP 0 Group 2: PEEP 5 Group 3: PEEP 10"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>45}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-15", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-02", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP values", "timeFrame"=>"Intraoperatively", "description"=>"comparison of diameter of optic nerve sheath (ONSD) for different PEEP values with ultrasonography (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)"}, {"measure"=>"comparison of diaphragmatic thickness with USG for different PEEP values", "timeFrame"=>"Intraoperatively", "description"=>"comparison of diaphragmatic thickness with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)"}, {"measure"=>"comparison of lung ultrasound scores (LUS) via USG for different PEEP values", "timeFrame"=>"Intraoperatively", "description"=>"comparison of lung scores with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O). This measurement calculated by\n\nLUS assigns 0 points to A lines or \\< 2 separate B lines plus regular sliding; 1 point with lines B ≥ 3 or spaced focal points plus regular sliding; 2 points with coalescing B lines, and 3 points to pulmonary consolidations with a score ranging from 0 (normal lungs) to 36 (worst case scenario)"}], "secondaryOutcomes"=>[{"measure"=>"comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures.", "timeFrame"=>"Intraoperatively", "description"=>"comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures. ( insufflation and desufflation) Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum.\n\nNormal intraabdominal pressure is 5-7 mmHg. Pneumoperitoneum is achieved by insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg."}, {"measure"=>"comparison of diaphragmatic thickness with USG with different intraabdominal pressures.", "timeFrame"=>"Intraoperatively", "description"=>"comparison of diaphragmatic thickness with USG in different intraabdominal pressures ( insufflation and desufflation) Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum."}, {"measure"=>"comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures.", "timeFrame"=>"Intraoperatively", "description"=>"comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures. ( insufflation and desufflation)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["laparoscopic surgery", "pneumoperitoneum", "optic nerve sheath diameter"], "conditions"=>["Cholecystitis"]}, "descriptionModule"=>{"briefSummary"=>"Laparoscopic surgeries are now more popular because of the advantages such as shorter hospital stay, minimal scar. In order to perform laparoscopic surgery, pneumoperitoneum should be initiated. The optic nerve sheath is an extension of the dura mater and the subarachnoid space is continuous with the intracranial subarachnoid space. Therefore, non-invasive monitoring of the increase in intracranial pressure (ICP) can be achieved by measuring the optic nerve and sheath diameter with ultrasound. Since ONSD measurement with ultrasound is an easily applicable technique, it is useful in monitoring intracranial pressure changes based on the optic nerve diameter during intraoperative changes", "detailedDescription"=>"Laparoscopic surgeries are now becoming increasingly common compared to traditional laparotomies, as they have advantages such as more minimal scarring, shorter hospital stay, fewer complications, and early mobilization. In these surgeries, pneumoperitoneum provided with carbon dioxide (CO2) has many effects on the cardiovascular, pulmonary, renal, metabolic and cerebral systems. Pulmonary compliance and functional residual capacity decrease due to pnemoperitoneum, ventilation/perfusion mismatch occurs, and as a result, hypoxemia may occur. A minimum of 4-6 cm H20 positive end-expiratory pressure (PEEP) should be applied to all intubated patients under general anesthesia to reduce postoperative pulmonary complications (especially atelectasis) and prevent ventilation/perfusion mismatch and hypoxemia. The optic nerve sheath is an extension of the dura mater and the subarachnoid space is continuous with the intracranial subarachnoid space. Therefore, non-invasive monitoring of the increase in intracranial pressure (ICP) can be achieved by measuring the optic nerve and sheath diameter with ultrasound. When ICP is \\> 20 mm Hg, measuring the optic nerve sheath diameter (ONSD) between 5.2 and 5.9 mm has a sensitivity of 74-95% and a specificity of 74-100%. Since ONSD measurement with ultrasound is an easily applicable technique, it is useful in monitoring intracranial pressure changes based on the optic nerve diameter during intraoperative changes (trendelenburg/reverse trendelenburg position, pneumoperitoneum , PEEP in mechanical ventilation)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 18- 65 aged all female and male volunteers\n\nExclusion Criteria:\n\n* acute or chronic eye diseases,\n* uncontrolled hypertension,\n* asthma\n* known lung disease,\n* body mass index (BMI) over 35 kg/m2,\n* devices using bulbs with known intracranial charging,\n* who refuse to participate in care"}, "identificationModule"=>{"nctId"=>"NCT06224868", "briefTitle"=>"Comparison of the Effects of Different PEEP Values With USG on Optic Nerve Sheath Diameter", "organization"=>{"class"=>"OTHER", "fullName"=>"Baskent University"}, "officialTitle"=>"Comparison of the Effects of Different PEEP Values With USG on Optic Nerve Sheath Diameter (ONSD), Diaphragmatic Thickness ,and Lung Score in Laparoscopic Surgery Patients", "orgStudyIdInfo"=>{"id"=>"KA 23/230"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"PEEP 0", "description"=>"After the patient is intubated, PEEP 0 will be set on the mechanical ventilator.", "interventionNames"=>["Other: insufflation", "Other: desufflation"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"PEEP 5", "description"=>"After the patient is intubated, PEEP 5 will be set on the mechanical ventilator.", "interventionNames"=>["Other: insufflation", "Other: desufflation"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"PEEP 10", "description"=>"After the patient is intubated, PEEP 10 will be set on the mechanical ventilator.", "interventionNames"=>["Other: insufflation", "Other: desufflation"]}], "interventions"=>[{"name"=>"insufflation", "type"=>"OTHER", "description"=>"Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg (Normal values are 5-7 mmHg) it is aimed to monitor optic sheat nerve diameter and lung ultrasound score changes with different intraabdominal pressures.", "armGroupLabels"=>["PEEP 0", "PEEP 10", "PEEP 5"]}, {"name"=>"desufflation", "type"=>"OTHER", "description"=>"Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg. When the surgery is completed, the trochars are removed and intra-abdominal pressure is returned to normal which is 5-7 mmHg.", "armGroupLabels"=>["PEEP 0", "PEEP 10", "PEEP 5"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Begum N Gokdemir", "role"=>"CONTACT", "email"=>"begokdemir@yahoo.com", "phone"=>"03122036868"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Baskent University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Research Assistant", "investigatorFullName"=>"Begüm Nemika Gökdemir", "investigatorAffiliation"=>"Baskent University"}}}}
