Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-03 @ 3:44 AM
Study NCT ID:
NCT02516566
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2015-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2015-08-03', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic nerve sheath diameter', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'Peak airway pressure', 'timeFrame': 'intraoperative'}, {'measure': 'Arterial blood pressure', 'timeFrame': 'intraoperative'}, {'measure': 'Heart rate', 'timeFrame': 'intraoperative'}, {'measure': 'Arterial carbon dioxide tension', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Positive end-expiratory pressure ventilation', 'Optic nerve sheath diameter'], 'conditions': ['Other Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '28107408', 'type': 'DERIVED', 'citation': 'Chin JH, Kim WJ, Lee J, Han YA, Lim J, Hwang JH, Cho SS, Kim YK. Effect of Positive End-Expiratory Pressure on the Sonographic Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure during Robot-Assisted Laparoscopic Prostatectomy: A Randomized Controlled Trial. PLoS One. 2017 Jan 20;12(1):e0170369. doi: 10.1371/journal.pone.0170369. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.', 'detailedDescription': 'Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy\n\nExclusion Criteria:\n\n* Patients who have cerebrovascular disease or history of cerebrovascular disease\n* Patients who are younger than 20 years'}, 'identificationModule': {'nctId': 'NCT02516566', 'briefTitle': 'Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Effects of Positive End-Expiratory Pressure Ventilation on Optic Nerve Sheath Diameter in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy', 'orgStudyIdInfo': {'id': 'AsanMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEP group', 'description': 'Mechanical ventilation with PEEP 8 cmH2O', 'interventionNames': ['Other: PEEP']}, {'type': 'NO_INTERVENTION', 'label': 'No PEEP group', 'description': 'Mechanical ventilation with no PEEP'}], 'interventions': [{'name': 'PEEP', 'type': 'OTHER', 'description': 'Mechanical ventilation with PEEP 8 cmH2O', 'armGroupLabels': ['PEEP group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Young-Kug Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young-Kug Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}