Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-27 @ 6:58 AM
Study NCT ID:
NCT06861959
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2025-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position
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': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peak inspiratory pressure (Ppeak) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'The primary outcome of the study was to compare peak inspiratory pressure (Ppeak) (cmH₂O) among the VCV, PCV, and PCV-VG ventilation modes in patients undergoing laparoscopic gynecologic surgery in the steep Trendelenburg position. Data were collected at four predefined time points during the study.\n\nThe first time point (T1) was measured 15 minutes after the induction of anesthesia, with patients in the supine position. The second time point (T2) was recorded 30 minutes following CO₂ insufflation and positioning in the Trendelenburg position. The third time point (T3) represented measurements taken 60 minutes after the initiation of pneumoperitoneum. The final time point (T4) was assessed 15 minutes after CO₂ deflation and the return of patients to the supine position.'}], 'secondaryOutcomes': [{'measure': 'Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'Mean Inspiratory Pressure (Pmean) (cmH₂O)\n\nVentilation variables was recorded at T1 to T4.'}, {'measure': 'Plateau Pressure (Pplateau) (cmH₂O) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'Plateau Pressure (Pplateau) (cmH₂O)\n\nVentilation variables was recorded at T1 to T4.'}, {'measure': 'Dynamic Lung Compliance (Cdyn) (mL/cmH₂O) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'Dynamic Lung Compliance (Cdyn) (mL/cmH₂O)\n\nVentilation variables was recorded at T1 to T4.'}, {'measure': 'Respiratory Rate (RR) (breaths per minute) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'Respiratory Rate (RR) (breaths per minute)\n\nVentilation variables was recorded at T1 to T4.'}, {'measure': 'Exhaled Tidal Volume (Exhale TV) (mL) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'Exhaled Tidal Volume (Exhale TV) (mL)\n\nVentilation variables was recorded at T1 to T4.'}, {'measure': 'Hemodynamic parameters: Heart Rate (HR) (beats per minute) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'Heart Rate (HR) (beats per minute)\n\nhemodynamic parameters were recorded at T1 to T4'}, {'measure': 'Hemodynamic parameters:Mean Arterial Pressure (MAP) (mmHg) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'Mean Arterial Pressure (MAP) (mmHg)\n\nhemodynamic parameters were recorded at T1 to T4'}, {'measure': 'Hemodynamic parameters: Peripheral Oxygen Saturation (SpO₂) (%) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'Peripheral Oxygen Saturation (SpO₂) (%)\n\nhemodynamic parameters were recorded at T1 to T4'}, {'measure': 'Hemodynamic parameters:End-Tidal CO₂ (EtCO₂) (mmHg) among the groups', 'timeFrame': '15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation', 'description': 'End-Tidal CO₂ (EtCO₂) (mmHg)\n\nhemodynamic parameters were recorded at T1 to T4'}, {'measure': 'arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups', 'timeFrame': '15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum', 'description': 'Arterial Partial Pressure of Oxygen (PaO₂) (mmHg)\n\nArterial blood gas analysis was conducted at T1 and T3.'}, {'measure': 'arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups', 'timeFrame': '15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum', 'description': 'Arterial Partial Pressure of Carbon Dioxide (PaCO₂) (mmHg)\n\nArterial blood gas analysis was conducted at T1 and T3.'}, {'measure': 'arterial blood gas analysis: Arterial Oxygen Saturation (SaO₂) (%) among the groups', 'timeFrame': '15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum', 'description': 'Arterial Oxygen Saturation (SaO₂) (%)\n\nArterial blood gas analysis was conducted at T1 and T3.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation', 'Laparoscopic Gynecologic Surgery', 'Peak Inspiratuar Pressure']}, 'referencesModule': {'references': [{'pmid': '31836201', 'type': 'BACKGROUND', 'citation': 'Toker MK, Altiparmak B, Uysal AI, Demirbilek SG. [Comparison of pressure-controlled volume-guaranteed ventilation and volume-controlled ventilation in obese patients during gynecologic laparoscopic surgery in the Trendelenburg position]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):553-560. doi: 10.1016/j.bjan.2019.09.003. Epub 2019 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\nThis study aimed to compare the effects of three different mechanical ventilation modes-Volume-Controlled Ventilation (VCV), Pressure-Controlled Ventilation (PCV), and Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)-on pulmonary and hemodynamic variables during laparoscopic gynecologic surgery in the steep Trendelenburg position. The hypothesis was that PCV and PCV-VG would be superior to VCV in optimizing respiratory mechanics and improving oxygenation, particularly by reducing peak inspiratory pressure (Ppeak).\n\nMethods:\n\nProspective, randomized, controlled clinical trial. Sixty ASA I-III patients aged 20-65 years undergoing elective laparoscopic gynecologic surgery in the steep Trendelenburg position were included (20 patients per ventilation group).\n\nPatients were randomized into VCV, PCV, and PCV-VG groups. Intraoperative ventilation was performed with a tidal volume of 8 mL/kg, PEEP of 5 cmH2O, and intra-abdominal pressure maintained at 12-14 mmHg.\n\nData were collected at four time points: T1 (after induction, supine), T2 (30 min after CO2 insufflation, Trendelenburg), T3 (60 min after pneumoperitoneum), and T4 (after CO2 deflation, supine).\n\nPrimary outcome: Ppeak comparison between groups. Secondary outcomes: Dynamic lung compliance (Cdyn), mean inspiratory pressure (Pmean), gas exchange, and hemodynamic parameters.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study included patients aged 20-65 years\n* Classified as American Society of Anesthesiologists (ASA) physical status I or III\n* who were scheduled to undergo an elective laparoscopic gynecologic surgery with pneumoperitoneum lasting at least one hour in the steep Trendelenburg position.\n\nExclusion Criteria:\n\n* morbid obesity (BMI \\> 40 kg/m²)\n* pulmonary or cardiac diseases (e.g., chronic obstructive pulmonary disease, heart failure)\n* a history of difficult intubation\n* Patients requiring conversion to laparotomy or experiencing hemodynamic instability during surgery'}, 'identificationModule': {'nctId': 'NCT06861959', 'briefTitle': 'Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'keahanest'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group VCV', 'description': 'Patients in this group were ventilated using Volume-Controlled Ventilation (VCV) mode throughout the procedure.', 'interventionNames': ['Device: Device: Volume-Controlled Ventilation (VCV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group PCV', 'description': 'Patients in this group were ventilated using Pressure-Controlled Ventilation (PCV) mode throughout the procedure.', 'interventionNames': ['Device: Device: Pressure-Controlled Ventilation (PCV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group PCV-VG', 'description': 'Patients in this group were ventilated using Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG) mode throughout the procedure.', 'interventionNames': ['Device: Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)']}], 'interventions': [{'name': 'Device: Volume-Controlled Ventilation (VCV)', 'type': 'DEVICE', 'description': 'Tidal volume: 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)', 'armGroupLabels': ['Group VCV']}, {'name': 'Device: Pressure-Controlled Ventilation (PCV)', 'type': 'DEVICE', 'description': 'Initial peak inspiratory pressure adjusted to deliver a tidal volume of 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)', 'armGroupLabels': ['Group PCV']}, {'name': 'Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)', 'type': 'DEVICE', 'description': 'Pressure-controlled mode with volume guarantee to maintain a tidal volume of 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)', 'armGroupLabels': ['Group PCV-VG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Üsküdar', 'country': 'Turkey (Türkiye)', 'facility': "Zeynep Kamil Maternity and Children's Training and Research Hospital", 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesiology and reanimation specialist doctor', 'investigatorFullName': 'kübra taşkın', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}