[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561496":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":46,"collaborators":26,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":26,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":26,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":26,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Qianfoshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Using a new oropharyngeal airway set","EXPERIMENTAL","Prior to induction of anesthesia and until the end of the gastroenteroscopy, oxygen was continuously supplied through a catheter partially attached to the endoscopic bite.",[13],"Device: Group using new oropharyngeal airway (experimental group)",{"label":15,"type":16,"description":17,"interventionNames":18},"The conventional endoscopic bite group","ACTIVE_COMPARATOR","Oxygen was administered continuously through a common nasal catheter until the end of the gastroenteroscopy prior to induction of anesthesia",[19],"Device: The conventional endoscopic biting group (control group)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Group using new oropharyngeal airway (experimental group)","Before anesthesia induction, study participants in the experimental group received 5-6L\u002Fmin oxygen for about 1min through an endoscopic bite oxygen supply device, and anesthesia induction was administered with propofol 3mg\u002Fkg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. When participants achieved sufficient sedation (about BIS40), they were placed into the oropharyngeal airway through the endoscopic bite and began gastroscopy.Anesthetic maintenance was administered with a continuous pump of 5mg\u002Fkg·h propofol until completion of the examination.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"The conventional endoscopic biting group (control group)","Prior to induction of anesthesia, control study participants inhaled 5 to 6L\u002Fmin of oxygen through a nasal catheter for approximately 1 minute.Anesthesia was induced by propofol 3mg\u002Fkg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. The endoscopic procedure began when the study participants reached sufficient sedation (about BIS40) and the ordinary endoscopic bite group reached sufficient sedation.Anesthetic maintenance was administered with a continuous pump of 5mg\u002Fkg·h propofol until completion of the examination.",[15],[32],{"name":33,"affiliation":34,"role":35},"Jianbo Wu","Department director","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Jianbo Wu, Doctorate","CONTACT","18560083793","jianbowu@126.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Qi You, Master","19553100910","312011097@qq.com",{"type":35,"investigatorFullName":33,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"chief physician","100561496","application-of-new-oropharyngeal-airway-management-in-obese-patients-undergoing-painless-gastroenteroscopy-100561496",false,"NCT06590922","Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy","Inclusion Criteria:\n\n* Age 18-65 years\n* 30≤BMI≤40\n* Written informed consent of patient or family\n* painless stomach + colonoscopy\n* ASA grade I-II\n\nExclusion Criteria：\n\n* Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation;\n* Severe cardiac insufficiency (≤4mets);\n* Patients with severe renal insufficiency;\n* diagnosed severe hepatic insufficiency;\n* Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;\n* Increased intracranial pressure;\n* Upper respiratory tract infections such as mouth, nose or throat;\n* Fever (core body temperature ≥37.5℃);\n* A confirmed diagnosis of pregnancy or breastfeeding;\n* Allergic to sedatives such as propofol or equipment such as tape;\n* Emergency surgery;\n* Multiple trauma;\n* SpO2 \\\u003C 95% before operation;\n* A history of drug and\u002For alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);\n* Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;\n* Currently participating in other clinical trials;\n* Patients who are deemed unfit by the investigator to participate in the trial;\n* Patients with a history of smoking were excluded",true,"ALL","18 Years","65 Years",{"count":59,"type":60},226,"ESTIMATED","INTERVENTIONAL",[63],"NA","Painless endoscopy is a popular method of endoscopic diagnosis and treatment. Propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has a significant respiratory center inhibition effect, resulting in a decrease in blood oxygen saturation of patients, especially obese patients, who are more likely to suffer from a sudden drop in blood oxygen and even threaten their lives .Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypopnea may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, resulting in hypoxia in patients. In addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients .Currently, there is no special oropharyngeal ventilation device used during gastroenteroscopy. Recently, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the conventional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the air tightness inside the nose mask and maximize the oxygen supply efficiency. The carbon dioxide outlet connected to the oropharyngeal airway body can not only collect the patient's exhaled gas, but also reduce the backflow of carbon dioxide gas.It can also access carbon dioxide detection equipment to monitor the patient's PCO2 at the end of breath in real time .In order to evaluate whether the new oropharyngeal airway can reduce the incidence of hypoxia in ordinary patients during painless gastroenteroscopy, the investigators prepared this study and explored the safety and effectiveness of the new oropharyngeal airway .",[66,67,68],"Obesity","Gastrointestinal Endoscopy","Airway Management","NOT_YET_RECRUITING","2024-09-08",{"date":72,"type":73},"2024-09-19","ACTUAL",{"date":75,"type":60},"2024-10-01",{"date":77,"type":60},"2025-12-01",{"name":5,"class":6}]