Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-26 @ 5:41 AM
Study NCT ID:
NCT05261295
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2022-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of PEEP Effect on Perioperative Oxygenation and Postoperative Pulmonary Complications in Lithotomy Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}, 'targetDuration': '6 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LUS score preop', 'timeFrame': 'Baseline', 'description': 'Loss of ventilation will be evaluated by calculating the LUS score. Each region will be scored according to the LUS model as follows: Presence of lung deviation with lines or less than two isolated B-lines is scored as 0; 1 point in the presence of more than one well-defined B line; presence of more than one combined B line, 2 points; and when a tissue pattern characterized by dynamic air bronchograms (lung consolidation) is presented, the score is 3. The worst ultrasound pattern observed in each region will be recorded and used to calculate the sum of the scores.'}, {'measure': 'LUS score postoperative', 'timeFrame': 'postoperative 1.hour', 'description': 'Loss of ventilation will be evaluated by calculating the LUS score. Each region will be scored according to the LUS model as follows: Presence of lung deviation with lines or less than two isolated B-lines is scored as 0; 1 point in the presence of more than one well-defined B line; presence of more than one combined B line, 2 points; and when a tissue pattern characterized by dynamic air bronchograms (lung consolidation) is presented, the score is 3. The worst ultrasound pattern observed in each region will be recorded and used to calculate the sum of the scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Positive End Expiratory Pressure', 'Lung Ultrasound']}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to compare the effectiveness of PEEP application in terms of perioperative oxygenation level in the use of classical LMA and i-gel, which is often preferred. The secondary aim is to compare parameters such as gastric insufflation and the rate of postoperative pulmonary complication development in the case of PEEP with two supraglottic airway devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III\n* Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy\n\nExclusion Criteria:\n\n* Heart failure (ejection fraction \\< 40%),\n* unstable hemodynamic conditions\n* Having neck or upper respiratory tract pathology,\n* have an increased risk of aspiration (gastroesophageal reflux disease, full stomach, acidity),\n* obesity (body mass index≥30 kg m-2)\n* Patients with poor tooth structure will also be excluded.'}, 'identificationModule': {'nctId': 'NCT05261295', 'briefTitle': 'Comparison of PEEP Effect on Perioperative Oxygenation and Postoperative Pulmonary Complications in Lithotomy Position', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of PEEP Applying in Terms of Perioperative Oxygenation and Postoperative Pulmonary Complications in the Use of Classical LMA and I-gel in Urological Surgery Procedures in Lithotomy Position', 'orgStudyIdInfo': {'id': 'E1-21-2260'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Classical LMA', 'description': 'Patients who received general anesthesia with classical LMA', 'interventionNames': ['Diagnostic Test: PEEP', 'Diagnostic Test: ZEEP']}, {'label': 'i-Gel', 'description': 'Patients who received general anesthesia with i-Gel', 'interventionNames': ['Diagnostic Test: PEEP', 'Diagnostic Test: ZEEP']}], 'interventions': [{'name': 'PEEP', 'type': 'DIAGNOSTIC_TEST', 'description': 'PEEP of 7 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.', 'armGroupLabels': ['Classical LMA', 'i-Gel']}, {'name': 'ZEEP', 'type': 'DIAGNOSTIC_TEST', 'description': 'PEEP of 0 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.', 'armGroupLabels': ['Classical LMA', 'i-Gel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmet Demirörs, MD', 'role': 'CONTACT', 'email': 'drahmetdemirors@gmail.com', 'phone': '+905548997181'}, {'name': 'canan ün, MD', 'role': 'CONTACT', 'email': 'cananun@yahoo.com', 'phone': '905306450054'}], 'overallOfficials': [{'name': 'canan ün, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ankara ch bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'canan ün', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}