Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 7:04 PM
Study NCT ID:
NCT05367557
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-05-04', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hearth rate', 'timeFrame': 'before the induction of anesthesia', 'description': 'hearth rate variations'}, {'measure': 'hearth rate', 'timeFrame': 'after the anesthesia induction but before incision', 'description': 'hearth rate variations'}, {'measure': 'hearth rate', 'timeFrame': '30 minutes after the pneumoperitoneum induction', 'description': 'hearth rate variations'}, {'measure': 'hearth rate', 'timeFrame': '5 minutes after the pneumoperitoneum releasing', 'description': 'hearth rate variations'}, {'measure': 'arterial blood pressure', 'timeFrame': 'before the induction of anesthesia', 'description': 'average arterial blood pressure variations'}, {'measure': 'arterial blood pressure', 'timeFrame': 'after the anesthesia induction but before incision', 'description': 'average arterial blood pressure variations'}, {'measure': 'arterial blood pressure', 'timeFrame': '30 minutes after the pneumoperitoneum induction', 'description': 'average arterial blood pressure variations'}, {'measure': 'arterial blood pressure', 'timeFrame': '5 minutes after the pneumoperitoneum releasing', 'description': 'average arterial blood pressure variations'}, {'measure': 'respiratory frequency', 'timeFrame': 'before the induction of anesthesia', 'description': 'respiratory frequency variations'}, {'measure': 'respiratory frequency', 'timeFrame': 'after the anesthesia induction but before incision', 'description': 'respiratory frequency variations'}, {'measure': 'respiratory frequency', 'timeFrame': '30 minutes after the pneumoperitoneum induction', 'description': 'respiratory frequency variations'}, {'measure': 'respiratory frequency', 'timeFrame': '5 minutes after the pneumoperitoneum releasing', 'description': 'respiratory frequency variations'}, {'measure': 'oxygen saturation', 'timeFrame': 'before the induction of anesthesia', 'description': 'oxygen saturation variations'}, {'measure': 'oxygen saturation', 'timeFrame': 'after the anesthesia induction but before incision', 'description': 'oxygen saturation variations'}, {'measure': 'oxygen saturation', 'timeFrame': '30 minutes after the pneumoperitoneum induction', 'description': 'oxygen saturation variations'}, {'measure': 'oxygen saturation', 'timeFrame': '5 minutes after the pneumoperitoneum releasing', 'description': 'oxygen saturation variations'}, {'measure': 'blood gas analysis', 'timeFrame': 'before the induction of anesthesia', 'description': 'blood gas analysis variations'}, {'measure': 'blood gas analysis', 'timeFrame': 'after the anesthesia induction but before incision', 'description': 'blood gas analysis variations'}, {'measure': 'blood gas analysis', 'timeFrame': '30 minutes after the pneumoperitoneum induction', 'description': 'blood gas analysis variations'}, {'measure': 'blood gas analysis', 'timeFrame': '5 minutes after the pneumoperitoneum releasing', 'description': 'blood gas analysis variations'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood gas analysis alterations; hemodynamic alterations'], 'conditions': ['Pneumoperitoneum']}, 'descriptionModule': {'briefSummary': 'Clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. Cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. Increased partial pressure of carbon dioxide induces metabolic acidosis with further vascular suffering. Pneumoperitoneum reduces the pulmonary exchange volumes and bring renal suffering.\n\nMethods. The aim of this study is to evaluate the alterations in hemodynamic and hemogasanalysis parameters during the laparoscopic surgery at different pressure settings of pneumoperitoneum in order to assess the best pressure value.\n\nWe evaluated and compared intraoperative hemodynamic and hemogasanalytic alterations in two groups of patients respectively subdue to laparoscopic cholecystectomy at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B).', 'detailedDescription': 'We evaluated intraoperative hemodynamic and hemogasanalytic alterations in two groups of randomized patients respectively operated at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B) to highlight any significant alterations.\n\nThe clinical sample used in the study is composed by patients aged between 15 and 85 years affected by cholelithiasis and treated with laparoscopic cholecystectomy in the period between July 2019 and February 2020.\n\n20 patients, 9 men and 11 women, were enrolled. Group A included 10 patients, 5 men and 5 women, with an average age of 47.9 years. Group B included 10 patients, 4 men and 6 women, with an average age of 50.7 years.\n\nThe parameters evaluated were: heart rate (HR), average arterial blood pressure (BP), respiratory frequency (RF), oxygen saturation (SaO2), hemogasanalysis (PaO2, PaCO2, pH and HCO3-).\n\nThe measurements were made at four stages: before the induction of anesthesia, after the anesthesia induction but before incision, 30 minutes after the pneumoperitoneum induction, 5 minutes after the pneumoperitoneum releasing.\n\nThe hemodynamic parameters (HR, RF, BP, SaO2) were extrapolated from the multiparameter monitor for each evaluation. The hemogasanalytic values (PaO2, PaCO2, pH and HCO3) were evaluated by the radial arterial sampling. The average and standard deviation were calculated for the quantitative data normally distributed. For the comparison of the quantitative data, the t-student test was used. A value of p ≤ 0,05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged between 15 and 85 years affected by symptomatic cholelithiasis and treated with laparoscopic cholecystectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: cholelithiasis -\n\nExclusion Criteria: immunodeficiency disorders, chronic use of corticosteroids, non-compensated diabetes mellitus, major morbidity with a life expectancy of less than 30 days, significant anemia (hemoglobin \\< 7 gr/Dl or hematocrit \\< 21%), coagulopathies, ascites, chronic pain treatment, severe comorbidities\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05367557', 'briefTitle': 'Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Laparoscopic Surgery: Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values', 'orgStudyIdInfo': {'id': 'UCatania000'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'pneumoperitoneum pressure of 12 mmHg', 'interventionNames': ['Procedure: laparoscopic cholecystectomy']}, {'label': 'Group B', 'description': 'pneumoperitoneum pressure of 8 mmHg', 'interventionNames': ['Procedure: laparoscopic cholecystectomy']}], 'interventions': [{'name': 'laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'removal of the gallbladder by laparoscopy at pneumoperitoneum pressure setting of 12 or 8 mmHg', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95123', 'city': 'Catania', 'country': 'Italy', 'facility': 'Eva Intagliata', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eva Intagliata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Eva Intagliata', 'investigatorAffiliation': 'University of Catania'}}}}