Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-04 @ 11:59 AM
Study NCT ID:
NCT02512120
Status:
WITHDRAWN
Last Update Posted:
2016-04-27
First Post:
2015-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The backgroud of this study was not well discussed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2015-07-29', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Arterial blood gas analysis', 'timeFrame': '4hours', 'description': 'Arterial blood gas analysis will be measured under specified ventilation mode.'}], 'primaryOutcomes': [{'measure': 'Airway pressure', 'timeFrame': '4hours', 'description': 'Airway pressure will be measured under specified ventilation mode.'}], 'secondaryOutcomes': [{'measure': 'Vital sign', 'timeFrame': '4hours', 'description': 'Vital sign will be measured under specified ventilation mode.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Volume controlled ventilation(VCV) is a most common used ventilation mode during general anesthesia. But VCV can cause high airway peak pressure when patient under steep Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure and improve dynamic compliance. We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.', 'detailedDescription': 'Robot assisted laparoscopic radical prostatectomy(RALP) has been used to treatment of prostate cancer since 2001. RALP offers some advantage such as reduced blood loss, sparing nerves, less postoperative pain. However, RALP require steep Trendelenberg position with pneumoperitoneum. It can cause increased airway peak pressure and unwanted hemodynamic effect under conventional volume controlled ventilation(VCV). Autoflow-VCV use decelerating flow, can reduce airway peak pressure and improve dynamic compliance.\n\nWe will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age 19-65)\n* American Society of Anesthesiology Classification I-III\n\nExclusion Criteria:\n\n* cardiovascular disease, cerebrovascular disease, pulmonary disease\n* over BMI 30'}, 'identificationModule': {'nctId': 'NCT02512120', 'acronym': 'VCVAFVCV', 'briefTitle': 'Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Comparison of Volume Controlled Ventilation(VCV) vs Autoflow-volume Controlled Ventilation(Autoflow-VCV) During Robot-assisted Laparoscopic Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'Autoflow46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'volume controlled ventilation', 'description': 'Randomized 23 patients will be applied VCV during RALP.', 'interventionNames': ['Device: volume controlled ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'autoflow-volume controlled ventilation', 'description': 'Randomized 23 patients will be applied autoflow-VCV during RALP.', 'interventionNames': ['Device: autoflow-volume controlled ventilation']}], 'interventions': [{'name': 'volume controlled ventilation', 'type': 'DEVICE', 'description': 'After induction of anesthesia and intubation, patients will be applied VCV by Zeus®(Dräger, Germany).\n\n\\- Tidal volume : 8ml/kg(ieal body weight), inspiration:expiration ratio = 1:2, FiO2 = 0.5, fresh gas flow = 3L/min respiratory rate(RR) : 12/min. After position, RR can changed 2 times each per 5 minutes to maintain end tidal CO2 around 35. Positive end expiratory pressure will not used.', 'armGroupLabels': ['volume controlled ventilation']}, {'name': 'autoflow-volume controlled ventilation', 'type': 'DEVICE', 'description': 'After induction of anesthesia and intubation, patients will be applied autoflow- VCV by Zeus®(Dräger, Germany).\n\n\\- Tidal volume : 8ml/kg(ideal body weight), inspiration:expiration ratio = 1:2, FiO2 = 0.5, fresh gas flow = 3L/min respiratory rate(RR) : 12/min. After position, RR can changed 2 times each per 5 minutes to maintain end tidal CO2 around 35. Positive end expiratory pressure will not used.', 'armGroupLabels': ['autoflow-volume controlled ventilation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hye-Won Shin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of anesthesiology and pain medicine, Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, MD, PhD', 'investigatorFullName': 'Hye-Won Shin', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}