Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT02436018
Status:
UNKNOWN
Last Update Posted:
2015-05-06
First Post:
2015-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'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': 1800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-01', 'studyFirstSubmitDate': '2015-04-26', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low pulse oximetry incidence', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours'}], 'secondaryOutcomes': [{'measure': 'Other adverse events', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': 'The adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy will be recorded. Adverse events associated with jet ventilation also be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sedation', 'Low pulse oximetry', 'Upper gastrointestinal endoscopy', 'WEI NASAL JET'], 'conditions': ['Peptic Ulcer', 'Gastric Cancer', 'Esophagus Cancer', 'Oesophagitis', 'Hypoxia']}, 'referencesModule': {'references': [{'pmid': '28974061', 'type': 'DERIVED', 'citation': 'Qin Y, Li LZ, Zhang XQ, Wei Y, Wang YL, Wei HF, Wang XR, Yu WF, Su DS. Supraglottic jet oxygenation and ventilation enhances oxygenation during upper gastrointestinal endoscopy in patients sedated with propofol: a randomized multicentre clinical trial. Br J Anaesth. 2017 Jul 1;119(1):158-166. doi: 10.1093/bja/aex091.'}]}, 'descriptionModule': {'briefSummary': 'Low pulse oximetry is the most common adverse events during sedation for upper gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing upper gastrointestinal endoscopy\n* age over 18 years old\n* Signed informed consent form\n\nExclusion Criteria:\n\n* a blood coagulation dysfunction or have a tendency of nose bleeding\n* a clear diagnosis of heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)\n* a clear diagnosis of lung disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer)\n* pregnant\n* liver disease\n* kidney disease\n* increase in intracranial pressure\n* emergency operation\n* multiple trauma\n* American Society of Anesthesiologists (ASA) Physical Status classification above IV\n* with mouth, nose and throat infection'}, 'identificationModule': {'nctId': 'NCT02436018', 'briefTitle': 'WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Safety and Efficacy Evaluation of The Nasopharyngeal Airway Embedded With Jet Ventilation Catheter(WEI NASAL JET) Applied for The Sedation of Outpatient Upper Gastrointestinal Endoscopy', 'orgStudyIdInfo': {'id': 'RenJiH-20150308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Oxygen(2L/min) supplied with nasal catheter'}, {'type': 'EXPERIMENTAL', 'label': 'Nasopharyngeal airway group', 'description': 'Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator', 'interventionNames': ['Device: Nasopharyngeal airway without jet ventilator']}, {'type': 'EXPERIMENTAL', 'label': 'WEI NASAL JET group', 'description': 'Oxygen supplied through WEI NASAL JET with a manual jet ventilator', 'interventionNames': ['Device: WEI NASAL JET']}], 'interventions': [{'name': 'WEI NASAL JET', 'type': 'DEVICE', 'otherNames': ['Nasopharyngeal airway embedded with jet ventilation catheter'], 'description': 'Oxygen is supplied through WEI NASAL JET by a manual jet ventilator', 'armGroupLabels': ['WEI NASAL JET group']}, {'name': 'Nasopharyngeal airway without jet ventilator', 'type': 'DEVICE', 'description': 'Oxygen is supplied directly through WEI NASAL JET without jet ventilator', 'armGroupLabels': ['Nasopharyngeal airway group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200065', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoqing Zhang, M.S.', 'role': 'CONTACT', 'email': 'xq_820175@163.com'}], 'facility': 'Shanghai Tongji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Qin, Master', 'role': 'CONTACT', 'email': '15921180801@163.com', 'phone': '+862168383702'}, {'name': 'Diansan Su, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yi Qin, Master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Renji hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lizhi Li, M.S.', 'role': 'CONTACT', 'email': 'Fmlilizhi@sina.com.cn'}], 'facility': "Shanghai Pudong New Area People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Diansan Su, Dr.', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+862168383702'}], 'overallOfficials': [{'name': 'Diansan Su, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Shanghai Pudong New Area People's Hospital", 'class': 'OTHER'}, {'name': 'Shanghai Tongji Hospital, Tongji University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'diansan su', 'investigatorAffiliation': 'RenJi Hospital'}}}}