Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-28 @ 2:50 AM
Study NCT ID:
NCT02071550
Status:
COMPLETED
Last Update Posted:
2014-02-26
First Post:
2014-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-21', 'studyFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in cerebral oxymetry during laparoscopy', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopic cholecystectomy, near infrared spectroscopy, positive end expiratory pressure'], 'conditions': ['Laparoscopic Cholecystectomy']}, 'descriptionModule': {'briefSummary': "In this study the investigators investigated changes in hemodynamic parameters and cerebral oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at the 30°head-up left side position, is compared with using two individual devices (INVOS-FORESIGHT).\n\nMethods: Afterwards the ethics committee approval of the hospital and receiving the written patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the right side forehead region. Totally 11 evaluation periods were formed, respectively: Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10 cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data, hemodynamic values and rSO2 values were recorded for both groups at all 11 periods."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing laparoscopic cholecystectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA(American Society of Anesthesiologist) class I and II\n* Patients undergoing laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* ASA class III and IV\n* Morbid obesity\n* Emergency cases\n* Cases returned to laparotomy'}, 'identificationModule': {'nctId': 'NCT02071550', 'acronym': 'NIRS AND PEEP', 'briefTitle': '10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turkiye Yuksek Ihtisas Education and Research Hospital'}, 'orgStudyIdInfo': {'id': '10869'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'zero PEEP', 'description': 'Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor', 'interventionNames': ['Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor', 'Device: FORESIGHT and INVOS monitor']}, {'label': '10 CM H2O PEEP', 'description': 'Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor', 'interventionNames': ['Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor', 'Device: FORESIGHT and INVOS monitor']}], 'interventions': [{'name': 'FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor', 'type': 'DEVICE', 'armGroupLabels': ['10 CM H2O PEEP', 'zero PEEP']}, {'name': 'FORESIGHT and INVOS monitor', 'type': 'DEVICE', 'armGroupLabels': ['10 CM H2O PEEP', 'zero PEEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06550', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turkiye Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'aslı demir', 'investigatorAffiliation': 'Turkiye Yuksek Ihtisas Education and Research Hospital'}}}}