Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:44 AM
Study NCT ID:
NCT07467135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Mechanics and Ventilation Efficiency in Robotic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilation Efficiency Index (VEI) change across robotic surgery phases', 'timeFrame': 'Intraoperative (T0-T4)', 'description': 'Evaluation of VEI changes between predefined intraoperative phases.'}], 'secondaryOutcomes': [{'measure': 'Mechanical Power Change', 'timeFrame': 'intraoperative', 'description': 'Evaluation of mechanical power changes across surgical phases.'}, {'measure': 'Static Lung Compliance Change', 'timeFrame': 'intraoperative', 'description': 'Evaluation of static compliance changes during robotic surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Robotic Surgery']}, 'descriptionModule': {'briefSummary': 'Robotic surgery requires pneumoperitoneum and specific surgical positioning such as steep Trendelenburg, reverse Trendelenburg, or supine positioning. These intraoperative conditions may lead to cranial displacement of the diaphragm, reduced lung compliance, and increased airway pressures, potentially impairing respiratory mechanics and gas exchange.\n\nPrevious studies have primarily evaluated respiratory mechanics during robotic surgery at single time points or within specific surgical procedures. However, dynamic changes occurring during critical phases of robotic surgery have rarely been evaluated prospectively.\n\nThis prospective observational cohort study aims to evaluate phase-specific changes in lung mechanics and ventilation efficiency during robotic surgery. Key parameters including mechanical power (MP), ventilation efficiency index (VEI), static compliance, and driving pressure will be analyzed across predefined intraoperative phases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing robotic surgery under general anesthesia with mechanical ventilation.\n\nRobotic procedures from different surgical specialties such as urology, gynecology, and general surgery will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥ 18 years\n* Patients undergoing robotic surgery\n* General anesthesia with mechanical ventilation\n* Written informed consent\n\nExclusion Criteria\n\n* Severe chronic pulmonary disease\n* Refusal to participate\n* Missing intraoperative ventilatory data'}, 'identificationModule': {'nctId': 'NCT07467135', 'briefTitle': 'Lung Mechanics and Ventilation Efficiency in Robotic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Phase-Specific Evaluation of Lung Mechanics and Ventilation Efficiency During Robotic Surgery: A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'TABED1-26-2262'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robotic Surgery', 'description': 'Adult patients undergoing robotic surgery under general anesthesia with mechanical ventilation. Intraoperative respiratory mechanics and gas exchange parameters will be prospectively recorded during predefined phases of robotic surgery (T0-T4). Parameters include ventilatory settings, airway pressures, arterial blood gas values, and calculated indices such as mechanical power, driving pressure, static compliance, and ventilation efficiency index. The study evaluates phase-specific changes in lung mechanics and ventilation efficiency during robotic surgical procedures.', 'interventionNames': ['Other: Intraoperative Mechanical Ventilation Monitoring']}], 'interventions': [{'name': 'Intraoperative Mechanical Ventilation Monitoring', 'type': 'OTHER', 'description': 'Prospective recording of ventilatory parameters and respiratory mechanics during robotic surgery under general anesthesia. Measurements will be obtained at predefined surgical phases (after intubation, pneumoperitoneum initiation, steep Trendelenburg positioning, undocking, and before extubation). Recorded parameters include tidal volume, respiratory rate, peak airway pressure, plateau pressure, positive end-expiratory pressure, arterial blood gas measurements, and calculated indices such as mechanical power, driving pressure, static compliance, and ventilation efficiency index.', 'armGroupLabels': ['Robotic Surgery']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assos. Prof', 'investigatorFullName': 'Betül Güven', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}