Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05222893
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2021-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of PEEP During Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019296', 'term': 'Capnography'}, {'id': 'D001784', 'term': 'Blood Gas Analysis'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio', 'timeFrame': '5 minutes before intubation,1 hour after surgery, 24 hour after surgery', 'description': 'Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement and compare between groups'}], 'secondaryOutcomes': [{'measure': 'Dynamics of the end-expiratory lung volume', 'timeFrame': '5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position', 'description': 'Calculation the end-expiratory lung volume (ml) and compare with expected and between groups'}, {'measure': 'Dynamics of the respiratory biomechanics', 'timeFrame': '5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position', 'description': 'Calculation the compliance of respiratory system (ml/mbar) and compare between groups at all time points'}, {'measure': 'Dynamics of the volume of CO2 eliminated per minute', 'timeFrame': '5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position', 'description': 'Measurement of volume of CO2 eliminated per minute (VCO2 in ml/min), than compare the trends as a marker of lung ventilation'}, {'measure': 'Dynamics of the partial pressure of CO2 in exhaled gas', 'timeFrame': '5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position', 'description': 'Measurement of partial pressure of CO2 in exhaled gas (PetCO2 in mmHg) than compare the trends as a marker of lung ventilation'}, {'measure': 'Dynamics of the hemodynamic parameters', 'timeFrame': '5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position', 'description': 'Measurement of the arterial blood pressure (mmHg) and compare between groups at all time points'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['positive end-expiratory pressure', 'esophageal pressure', 'laparoscopic surgery'], 'conditions': ['Post-Op Complication', 'Ventilator-Induced Lung Injury']}, 'referencesModule': {'references': [{'pmid': '24919591', 'type': 'BACKGROUND', 'citation': 'Barbosa FT, Castro AA, de Sousa-Rodrigues CF. Positive end-expiratory pressure (PEEP) during anaesthesia for prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD007922. doi: 10.1002/14651858.CD007922.pub3.'}, {'pmid': '26332856', 'type': 'BACKGROUND', 'citation': 'Bender SP, Paganelli WC, Gerety LP, Tharp WG, Shanks AM, Housey M, Blank RS, Colquhoun DA, Fernandez-Bustamante A, Jameson LC, Kheterpal S. Intraoperative Lung-Protective Ventilation Trends and Practice Patterns: A Report from the Multicenter Perioperative Outcomes Group. Anesth Analg. 2015 Nov;121(5):1231-9. doi: 10.1213/ANE.0000000000000940.'}, {'pmid': '30277931', 'type': 'BACKGROUND', 'citation': 'Kacmarek RM, Villar J. Lung-protective Ventilation in the Operating Room: Individualized Positive End-expiratory Pressure Is Needed! Anesthesiology. 2018 Dec;129(6):1057-1059. doi: 10.1097/ALN.0000000000002476. No abstract available.'}, {'pmid': '19001507', 'type': 'BACKGROUND', 'citation': "Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11."}, {'pmid': '25549487', 'type': 'BACKGROUND', 'citation': "Iaroshetskii AI, Protsenko DN, Rezepov NA, Gel'fand BR. [Positive end-expiratory pressure adjustment in parenchimal respiratory failure: static pressure-volume loop or transpulmonary pressure?]. Anesteziol Reanimatol. 2014 Jul-Aug;59(4):53-9. Russian."}, {'pmid': '30260897', 'type': 'BACKGROUND', 'citation': 'Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.'}]}, 'descriptionModule': {'briefSummary': 'Lung-protective ventilation (LPV) during general anesthesia can trigger the development of early postoperative pulmonary complication (PPC) and ventilator associated lung injury. One of the proven components of the LPV is low tidal volume (TV). Data on the positive end-expiratory pressure (PEEP) parameters adjustment in laparoscopic surgery, as well as the effects on the respiratory biomechanics, lung tissue and respiratory muscles damage are limited and not clear.\n\nThe objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.', 'detailedDescription': "During laparoscopic surgery pressure on alveoli increases, due to in the conditions of pneumoperitoneum, muscle relaxation, the patient's position on the operating table, excess body weight and other factors. As the consequence, the alveoli collapse due to negative transpulmonary pressure. The personalized PEEP adjustment for each particular patient during laparoscopic surgery can help to avoid the adverse effects on biomechanical parameters of the respiratory system, the early PPC incidence and improve overall patients' recovery.\n\nThe objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.\n\nInvestigators will measure if PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group) versus PEEP constantly set at 5 cmH2O (control group) gives better outcomes and prevent the early PPC incidence in hospitals.\n\nAfter the induction, intubation and insertion of the esophageal balloon catheter, TV for patients both groups is set to 6 ml / kg BMI: for men (50+0.91\\* (height-152.4), for women (45+0.91\\* (height-152.4); minute ventilation (MV) to ensure the level of PetCO2 - 30-35 mmHg, respiratory rate (RR) 15-25/min (maximum up to 35/min).\n\nGas exchange parameters including partial pressures of oxygen (PaO2) and carbon dioxide (PaCO2) in arterial blood will be measured before the induction (T0), after 1 hour after surgery (T5) and after 24 hours after surgery (T6), then will calculate PAO2/FiO2 respectively.\n\nFiO2, oxygen saturation (SpO2), hemodynamic parameters including blood pressure (BP), heart rate (HR) will be recorded in all point of the study.\n\nFollowing respiratory mechanics will be measured: plateau pressure (Pplat), PEEP, driving pressure (DP), Pes during inspiration and expiration, volumetric capnometry (VCO2), end-tidal carbon dioxide tension (PetCO2).\n\nRespiratory system compliance (Cstat, Cl, Ccw), end-expiratory lung volume (EELV) will calculated after intubation (T1), after PEEP set according to the patient's group allocation PEEP Pes and PEEP 5 (T2), after initiating pneumoperitoneum (T3) and placing the patient in the reverse Trendelenburg position (T4).\n\nThis is a randomized controlled study in the operating room of the University hospitals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopic surgery with mechanical lung ventilation American Society of Anesthesiologists Classification (ASA) I-III\n\nExclusion Criteria:\n\n* pregnancy\n* age less than 18 or more than 70 years\n* patients ASA \\> III\n* life-threatening heart rhythm abnormalities and/or systolic blood pressure \\< 80 mmHg despite norepinephrine at a dose \\> 2 μg/kg/min\n* primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumor metastases in the lungs\n* chronic decompensated diseases with extrapulmonary organ dysfunction (tumor progression, liver cirrhosis, congestive heart failure)\n* Glasgow coma score \\< 14\n* upper airways obstruction'}, 'identificationModule': {'nctId': 'NCT05222893', 'briefTitle': 'Optimization of PEEP During Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Karaganda Medical University'}, 'officialTitle': 'Optimization of Positive End-expiratory Pressure During Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'PEEP-TPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PEEP Pes', 'description': 'PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group)', 'interventionNames': ['Diagnostic Test: Respiratory monitoring', 'Diagnostic Test: Capnography', 'Diagnostic Test: Arterial blood gas', 'Device: Esophageal pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEEP 5', 'description': 'PEEP constantly set at 5 cmH2O (control group)', 'interventionNames': ['Diagnostic Test: Respiratory monitoring', 'Diagnostic Test: Capnography', 'Diagnostic Test: Arterial blood gas', 'Device: Esophageal pressure']}], 'interventions': [{'name': 'Respiratory monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of the plateau pressure, positive end-expiratory pressure, driving pressure, end-expiratory lung volume, compliance of respiratory system on volume-controlled ventilation', 'armGroupLabels': ['PEEP 5', 'PEEP Pes']}, {'name': 'Capnography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of end-tidal carbon dioxide tension, volume of CO2 eliminated per minute', 'armGroupLabels': ['PEEP 5', 'PEEP Pes']}, {'name': 'Arterial blood gas', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of the oxygen partial pressure and the carbon dioxide partial pressure', 'armGroupLabels': ['PEEP 5', 'PEEP Pes']}, {'name': 'Esophageal pressure', 'type': 'DEVICE', 'description': 'Measurement the pressure in the lower third of esophagus during inspiration and expiration', 'armGroupLabels': ['PEEP 5', 'PEEP Pes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010000', 'city': 'Astana', 'state': 'Select', 'country': 'Kazakhstan', 'facility': 'National Research Oncology and Transplantology Centre', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karaganda Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, {'name': 'National Research Oncology and Transplantology Center, Kazakhstan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}