[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561762":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":46,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":26,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":26,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"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","In the new oropharyngeal airway group (experimental group), oxygen was continuously supplied through a catheter partially attached to the endoscopic bite before induction of anesthesia until the end of gastroenteroscopy",[13],"Device: Group using new oropharyngeal airway (experimental group)",{"label":15,"type":16,"description":17,"interventionNames":18},"The conventional endoscopic bite group was used","ACTIVE_COMPARATOR","In the conventional endoscopic bite group (control group), oxygen was continuously supplied through a conventional nasal catheter before induction of anesthesia and until the end of gastroenteroscopy",[19],"Device: Endoscopic bite 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},"Endoscopic bite 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","Shandong First Medical University","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":47,"investigatorFullName":33,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","chief physician","100561762","observation-of-clinical-effect-of-new-oropharyngeal-airway-in-patients-with-oshas-during-painless-gastroenteroscopy-100561762",false,"NCT06594380","Observation of Clinical Effect of New Oropharyngeal Airway in Patients With OSHAS During Painless Gastroenteroscopy","Observation of Clinical Effect of New Oropharyngeal Airway in Patients With Obstructive Sleep Apnea Hypoapnea Syndrome During Painless Gastroenteroscopy","Inclusion Criteria:\n\n* Age 18-65 years old\n* evidence of polysleep monitoring for diagnosis of OSAHS\n* written informed consent of patient or family member\n* painless stomach + colonoscopy\n* ASA grade I-II\n\nExclusion criteria:\n\n* Patients with clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who could not perform oropharyngeal airway ventilation;\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 should not participate in this study.",true,"ALL","18 Years","65 Years",{"count":61,"type":62},130,"ESTIMATED","INTERVENTIONAL",[65],"NA","the(obstructivesleepapneahypoapneasyndromeOSAHS) is a kind of to sleep appear periodically in the process of syndrome characterized by partial or complete obstruction of upper respiratory tract.Patients with obstruction during the attack, faced with percutaneous arterial blood oxygen saturation (percutaneousarterialoxygensaturation, SpO2) to reduce the risk of can also trigger hypercapnia and cardiovascular dysfunction.The global incidence of OSAS is 4.0% in males and 2.0% in females .Sedative drugs inhibit the response of OSAS patients to external stimuli and may cause pharyngeal muscle collapse, leading to an increased risk of respiratory adverse events during painless gastroscopy in this population .In fact, OSAS has been identified as an independent risk factor for endoscopic hypoxia .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 during painless gastroenteroscopy in general patients, the study was designed to investigate the safety and efficacy of the new oropharyngeal airway.",[68,69,70],"OSAHS","Gastrointestinal Endoscopy","Airway Complication of Anesthesia","NOT_YET_RECRUITING","2024-09-10",{"date":74,"type":75},"2024-09-19","ACTUAL",{"date":77,"type":62},"2024-10-01",{"date":79,"type":62},"2025-12-01",{"name":33,"class":6}]