Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-29 @ 9:03 PM
Study NCT ID:
NCT05049395
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004716', 'term': 'Endometritis'}, {'id': 'D000093665', 'term': 'Septate Uterus'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000093662', 'term': 'Uterine Duplication Anomalies'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 960}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-09-08', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidence of severe hypoxia', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': 'SpO2 \\< 75% or 75% ≤ SpO2 \\<90% for \\>= 60 s'}, {'measure': 'The incidence of other adverse events', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': 'Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force'}], 'primaryOutcomes': [{'measure': 'The incidence of hypoxia', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': '75%≤SpO2\\<90% and \\<60S'}], 'secondaryOutcomes': [{'measure': 'The incidence of sub-clinical respiratory depression', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average about 2 hours', 'description': '90%≤SpO2\\<95%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFNO', 'Hysteroscopy', 'Sedation', 'Hypoxia'], 'conditions': ['Endometritis', 'Tuberculous Endometritis', 'Subseptate Uterus', 'Endometrial Polyps']}, 'descriptionModule': {'briefSummary': 'To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 20 years old ≤ age ≤ 50 years old, female.\n2. Undergoing hysteroscopy sedated with propofol for diagnosis or treatment.\n3. Informed consent\n4. BMI≤28kg/m2.\n5. ASA physical status Ⅰ\\~ Ⅱ.\n\nExclusion Criteria:\n\n1. Epistaxis, nasal congestion and nasal mucosal damage.\n2. Confirmed brain disease (cranial trauma, tumor, stroke, cognitive dysfunction etc.).\n3. Confirmed severe heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.).\n4. Confirmed severe lung diseases (upper respiratory tract infection, asthma, bronchitis, COPD, bullae, pulmonary embolism, pulmonary edema, lung cancer, etc.).\n5. Pregnant women.\n6. Acute and chronic hepatitis or liver cirrhosis with severe abnormal liver function.\n7. Acute and chronic nephritis with severe abnormal renal function or renal failure.\n8. Needing oxygen inhalation for underlying diseases.\n9. Emergency surgery.\n10. Combined with multiple trauma.\n11. Allergic to soybean'}, 'identificationModule': {'nctId': 'NCT05049395', 'briefTitle': 'HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'HFNO Reducing the Incidence of Hypoxia During the Procedure of Hysteroscopy Sedated With Propofol，a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'RJ20210904'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.', 'interventionNames': ['Device: Regular oxygen']}, {'type': 'EXPERIMENTAL', 'label': 'HFNO group', 'description': 'The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation.', 'interventionNames': ['Device: High Flow Nasal Cannula oxygen (HFNO)']}], 'interventions': [{'name': 'High Flow Nasal Cannula oxygen (HFNO)', 'type': 'DEVICE', 'description': 'The AIRVO2 is set at 30L/min, FiO2 100%, and 37℃ before anesthesia induction，and then 60L/min until the end of the procedure of sedated hysteroscopy.', 'armGroupLabels': ['HFNO group']}, {'name': 'Regular oxygen', 'type': 'DEVICE', 'description': 'The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Diansan Su', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+862168383702'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huang Yonglei, BA', 'role': 'CONTACT', 'email': '2367541746@qq.com', 'phone': '86 13641637003'}, {'name': 'Lu Qi, BA', 'role': 'CONTACT', 'phone': '86 21 68383364'}], 'overallOfficials': [{'name': 'Su Diansan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}