Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-01 @ 3:20 PM
Study NCT ID:
NCT07105293
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Peep Applications on Tissue Oxygenation, Respiratory Mechanics and Postoperative Pulmonary Complications in Laparoscopic Hysterectomy Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomized into two equal groups; one group received PEEP 5 cmH₂O, while the other received PEEP 10 cmH₂O.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intergroup comparison of near infrared spektroscopy (NIRS) value', 'timeFrame': 'During the operation', 'description': 'Comparison of near infrared spektroscopy (NIRS) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg baseline, after intubation, after pneumoperitoneum and after insufflation'}, {'measure': 'Pulmonary Outcomes', 'timeFrame': 'During the operation', 'description': 'It was determined whether pulmonary complications developed and its relationship with the Ariscat score was evaluated.\n\nAriscat score:\n\nLow Risk: 0-26 point Middle Risk: 26-44 point Hihg Risk: 45≤ point'}, {'measure': 'Intergroup comparison of peak inspiratory pressure (Ppeak) value (mmHg)', 'timeFrame': 'During the operation', 'description': 'Comparison of peak inspiratory pressure (Ppeak) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation'}, {'measure': 'Intergroup comparison of plato pressure (Ppeak) value (mmhg)', 'timeFrame': 'during the operation', 'description': 'Comparison of plato pressure (Pplato) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation'}, {'measure': 'Intergroup comparison of mean airway pressure (Pmean) value (mmhg)', 'timeFrame': 'during the operation', 'description': 'Comparison of mean airway pressure (Pmean) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation'}, {'measure': 'Intergroup comparison of end tidal carbondioxide (EtCO2) value (mmhg)', 'timeFrame': 'during the operations', 'description': 'Comparison of end tidal carbondioxide (EtCO2) values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation'}, {'measure': 'Intergroup comparison of driving pressure value (mmhg)', 'timeFrame': 'during the operations', 'description': 'Comparison of driving pressure values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation'}, {'measure': 'Intergroup comparison of partial oxygen pressures (PaO2) (mmhg)', 'timeFrame': 'during the operations', 'description': 'Comparison of partial oxygen pressures (pao2) in arterial blood gas between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation'}, {'measure': 'Intergroup comparison of partial carbondioxide pressures (PaCO2) (mmhg)', 'timeFrame': 'during the operations', 'description': 'Comparison of partial carbondioxide pressures (PaCO2) in arterial blood gas between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation'}, {'measure': 'Intergroup comparison of lactate value', 'timeFrame': 'during the operation', 'description': 'Comparison of lactate values between two groups with PEEP: 5 mmHg and PEEP: 10 mmHg after intubation, after pneumoperitoneum and after insufflation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic hysterectomy', 'PEEP', 'Postoperative pulmonary complications', 'Respiratory mechanics', 'Driving pressure', 'Tissue oxygenation'], 'conditions': ['Laparoscopy', 'Positive End Expiratory Pressure (PEEP)', 'Respiratory Mechanics']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effects of two different PEEP levels (5 cmH₂O and 10 cmH₂O) during laparoscopic hysterectomy on perioperative tissue and cerebral oxygenation, respiratory mechanics, and postoperative pulmonary complications.', 'detailedDescription': "Laparoscopic surgery is frequently performed today due to its rapid recovery, short hospital stay, minimal incisions, and minimal postoperative pain. Despite these advantages of laparoscopic hysterectomy, the patient's Trendelenburg position and pneumoperitoneum can cause abdominal organs to shift to the diaphragm, decrease lung compliance, atelectasis, and ultimately compromise respiratory function and mechanics. Tissue hypoxia occurs, affecting cerebral perfusion. Consequently, these patients are prone to perioperative hypoxemia and postoperative pulmonary complications. PEEP can improve arterial oxygenation and reduce atelectasis. The aim of this study was to compare the effectiveness of PEEP in terms of perioperative tissue oxygenation, cerebral perfusion, respiratory mechanics, and postoperative pulmonary complications.\n\nThe study was planned to include 64 patients aged 18-75 years, with ASA status I-III, who provided informed consent and were undergoing elective laparoscopic hysterectomy. The patients were randomized into two groups: one with PEEP 5 cmH₂O and the other with PEEP 10 cmH₂O. The aim was to compare the two groups' hemodynamic variables, NIRS values, peak inspiratory pressure (Ppeak), plateau pressure (Pplato), mean airway pressure (Pmean), end-tidal CO₂ (EtCO₂), driving pressure, serum lactate, partial arterial oxygen (PaO2), and carbon dioxide (PaCO2) levels, recorded after intubation, 30 minutes after pneumoperitoneum, and 15 minutes after desufflation. The ARISCAT score was used to assess the risk of any postoperative pulmonary complications."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study group included patients aged 18-70 years with ASA physical status I-III who were scheduled for elective laparoscopic hysterectomy under general anesthesia between November 1, 2023 and February 15, 2024 and who gave informed consent for participation.\n\nExclusion Criteria:\n\n* Previous history of pneumothorax\n* ASA IV classification\n* Significant pulmonary impairment (moderate/severe chronic obstructive pulmonary disease, emphysema, pulmonary hypertension, etc.)\n* Active upper respiratory tract infection or recurrent respiratory infections requiring recent antibiotic treatment\n* Severe systemic diseases\n* Heavy smoking (≥20 pack-years)\n* Emergency surgical cases\n* Failure to provide written informed consent for any reason\n* Contraindications to PEEP application'}, 'identificationModule': {'nctId': 'NCT07105293', 'briefTitle': 'Effects of Different Peep Applications on Tissue Oxygenation, Respiratory Mechanics and Postoperative Pulmonary Complications in Laparoscopic Hysterectomy Operations', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'Effects of Different Peep Applications on Tissue Oxygenation, Respiratory Mechanics and Postoperative Pulmonary Complications in Laparoscopic Hysterectomy Operations', 'orgStudyIdInfo': {'id': 'SBU-AVR-BS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PEEP 5 cmH2o applied group', 'description': 'A standardized anesthesia protocol involved volume-controlled ventilation with a tidal volume of 6-8 mL/kg and a frequency of 10-12 breaths/min. Patients were randomized into two equal groups; one group received PEEP 5 cmH₂O', 'interventionNames': ['Other: PEEP 5 cmH2o applied group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEEP 10 cmH2o applied group', 'description': 'A standardized anesthesia protocol involved volume-controlled ventilation with a tidal volume of 6-8 mL/kg and a frequency of 10-12 breaths/min. Patients were randomized into two equal groups; one group received PEEP 10 cmH₂O', 'interventionNames': ['Other: PEEP 10 cmH2o applied group']}], 'interventions': [{'name': 'PEEP 5 cmH2o applied group', 'type': 'OTHER', 'description': 'A standardized anesthesia protocol involved volume-controlled ventilation with a tidal volume of 6-8 mL/kg and a frequency of 10-12 breaths/min, PEEP:5 cmH2o', 'armGroupLabels': ['PEEP 5 cmH2o applied group']}, {'name': 'PEEP 10 cmH2o applied group', 'type': 'OTHER', 'description': 'A standardized anesthesia protocol involved volume-controlled ventilation with a tidal volume of 6-8 mL/kg and a frequency of 10-12 breaths/min, PEEP:10 cmH2o', 'armGroupLabels': ['PEEP 10 cmH2o applied group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kartal Dr. Lutfi Kirdar City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Büşra Şabano', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}