Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04259918
Status:
UNKNOWN
Last Update Posted:
2020-02-19
First Post:
2020-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Alveolar Recruitment Maneuver on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'enrolled groups ares only selected and applied in the operating room and participants, care giver and outcomes accessor could not know the group assignment'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-16', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numeric rating scale for postoperative pain', 'timeFrame': 'up to postoperative 24 hour', 'description': 'score (0 no pain-10 severe pain)'}, {'measure': 'Quality of recovery (QoR40) for Postoperative comfort', 'timeFrame': 'up to postoperative 24 hour', 'description': 'score 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O', 'detailedDescription': 'After random assignment of group, Control group: no additional procedure apply, Low ARM group : after surgical trocha out after bariatric surgery, applying 30cmH2O recruitment maneuver 5 times every 5 seconds, High ARM group: after surgical trocha out after bariatric surgery, applying 60cmH2O recruitment maneuver 5 times every 5 seconds'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who scheduled for elective bariatric surgery\n\nExclusion Criteria:\n\n* uncontrolled cardio-vascular disease, active pulmonary disorder'}, 'identificationModule': {'nctId': 'NCT04259918', 'briefTitle': 'Effect of Alveolar Recruitment Maneuver on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Effect of Alveolar Recruitment Maneuver on Postoperative Pain After Bariatric Surgery', 'orgStudyIdInfo': {'id': 'Gil2019-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'no applying alveolar recuritment maneuver', 'interventionNames': ['Procedure: Alveolar recruitment maneuver']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low ARM', 'description': 'Applying 30 cmH2O of alveolar recruitment maneuver 5 times every 5sec', 'interventionNames': ['Procedure: Alveolar recruitment maneuver']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High ARM', 'description': 'Applying 60 cmH2O of alveolar recruitment maneuver 5 times every 5sec', 'interventionNames': ['Procedure: Alveolar recruitment maneuver']}], 'interventions': [{'name': 'Alveolar recruitment maneuver', 'type': 'PROCEDURE', 'otherNames': ['Low pressure alveolar recruitment maneuver', 'High pressure alveolar recruitment maneuver'], 'description': 'Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery', 'armGroupLabels': ['Control', 'High ARM', 'Low ARM']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Youn Yi Jo', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}