Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-04-22 @ 10:49 PM
Study NCT ID:
NCT04872361
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2021-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind (Participant, Outcomes Assessor).'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-02', 'studyFirstSubmitDate': '2021-05-02', 'studyFirstSubmitQcDate': '2021-05-02', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-emergence LUS score', 'timeFrame': 'intraoperative before recovery from anesthesia', 'description': 'Lung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.'}], 'secondaryOutcomes': [{'measure': 'Lung ultrasonography score (LUS score)', 'timeFrame': 'preoperative, intraoperative for anesthesia duration to 1 hour postoperative', 'description': 'Lung ultrasonography score (LUS score) between groups'}, {'measure': 'Heart rate', 'timeFrame': 'preoperative, intraoperative for anesthesia duration to 1 hour postoperative', 'description': 'heart rate between groups at each time point of LUS score performance'}, {'measure': 'Mean blood pressure', 'timeFrame': 'preoperative, intraoperative to 1 hour postoperative', 'description': 'mean arterial blood pressure between groups at each time point of LUS score performance'}, {'measure': 'oxygen saturation', 'timeFrame': 'preoperative, intraoperative to 1 hour postoperative', 'description': 'patient oxygen saturation between groups at each time point of LUS score performance'}, {'measure': 'End-tidal carbon dioxide tension', 'timeFrame': 'intraoperative for anesthesia duration', 'description': 'end tidal CO2 between groups post induction, post recruitment and before extubation'}, {'measure': 'Arterial partial pressure of oxygen (PaO2)', 'timeFrame': 'Intraoperative and 15 min postoperative', 'description': 'arterial blood gases post induction, before extubation and at the PACU'}, {'measure': 'Arterial partial pressure of carbon dioxide (PaCO2)', 'timeFrame': 'Intraoperative and 15 min postoperative', 'description': 'arterial blood gases post induction, before extubation and at the PACU'}, {'measure': 'PaO2/FiO2', 'timeFrame': 'Intraoperative and 15 min postoperative', 'description': 'arterial blood gases post induction, before extubation and at the PACU'}, {'measure': 'Peak inspiratory pressure', 'timeFrame': 'intraoperative for anesthesia duration', 'description': 'peak inspiratory pressure between groups after intubation'}, {'measure': 'Postoperative pulmonary complications (PPCs)', 'timeFrame': '5 days', 'description': 'PPCs include (pneumothorax, pleural effusion, pulmonary collapse, atelectasis, pneumonia, acute respiratory distress syndrome (ARDS), or pulmonary aspiration).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia Induced Atelectasis']}, 'descriptionModule': {'briefSummary': 'Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation.\n\nApplied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.', 'detailedDescription': "The aim of our study is to assess the effect of using PEEP with and without recruitment maneuver on atelectasis and lung aeration during open upper abdominal surgeries by ultrasonography.\n\nApplication of PEEP improves intraoperative oxygenation and thus could minimize the incidence of postoperative atelectasis and respiratory complications during abdominal surgeries.\n\nA recent study found that PEEP and RM prevented intraoperative aeration loss, which didn't persist after extubation when comparing effects of positive end-expiratory pressure/recruitment maneuvers with zero end-expiratory pressure on atelectasis during open gynecological surgery by ultrasonography"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologists' physical status grades I, II, and III.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Psychiatric diseases.\n* Body Mass Index \\> 35 Kg/m2.\n* Previous intrathoracic procedures.\n* History of severe obstructive pulmonary disease.\n* History of severe restrictive lung disease.\n* Pulmonary arterial hypertension ( systolic pulmonary arterial pressure \\>40 mmHg).\n* Pregnancy."}, 'identificationModule': {'nctId': 'NCT04872361', 'briefTitle': 'Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies', 'orgStudyIdInfo': {'id': 'MFM-IRB.MD.21.01.412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Low PEEP', 'description': 'Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)', 'interventionNames': ['Procedure: Low PEEP', 'Device: Lung ultrasonogrphy assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High PEEP', 'description': 'High positive end-expiratory pressure (PEEP)', 'interventionNames': ['Procedure: High PEEP', 'Device: Lung ultrasonogrphy assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High PEEP/RM', 'description': 'High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)', 'interventionNames': ['Procedure: High PEEP/RM', 'Device: Lung ultrasonogrphy assessment']}], 'interventions': [{'name': 'Low PEEP', 'type': 'PROCEDURE', 'description': 'Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study', 'armGroupLabels': ['Low PEEP']}, {'name': 'High PEEP', 'type': 'PROCEDURE', 'description': 'PEEP of 10 cm H2O will be applied', 'armGroupLabels': ['High PEEP']}, {'name': 'High PEEP/RM', 'type': 'PROCEDURE', 'description': 'PEEP of 10 cm H2O and RM (30 cm H2O for 30 s) immediately after the second lung ultrasonographic examination and repeated every 30 minutes till emergence', 'armGroupLabels': ['High PEEP/RM']}, {'name': 'Lung ultrasonogrphy assessment', 'type': 'DEVICE', 'description': 'The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines\n\n1. three or more B lines\n2. coalescent B lines\n3. consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss', 'armGroupLabels': ['High PEEP', 'High PEEP/RM', 'Low PEEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Aboelnour E Badran, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Anesthesia and Surgical Intensive Care'}, {'name': 'Hanaa M EL- Bendary, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Anesthesia and Surgical Intensive Care'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'after completing the study and acceptance for publication', 'ipdSharing': 'YES', 'description': 'will be available after completing the study and acceptance for publication', 'accessCriteria': 'Sharing Criteria: the data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}