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Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy

226 participantsStarted 2024-10-01

Plain-language summary

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 .

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-65 years * 30≤BMI≤40 * Written informed consent of patient or family * painless stomach + colonoscopy * ASA grade I-II Exclusion Criteria： * 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; * Severe cardiac insufficiency (≤4mets); * Patients with severe renal insufficiency; * diagnosed severe hepatic insufficiency; * Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy; * Increased intracranial pressure; * Upper respiratory tract infections such as mouth, nose or throat; * Fever (core body temperature ≥37.5℃); * A confirmed diagnosis of pregnancy or breastfeeding; * Allergic to sedatives such as propofol or equipment such as tape; * Emergency surgery; * Multiple trauma; * SpO2 \< 95% before operation; * A history of drug and/or 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); * 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, myastheni…

What they're measuring

Incidence of hypoxia

Timeframe: 1 minute after anesthesia induction

Trial details

NCT IDNCT06590922

SponsorQianfoshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

Contact for this trial

Jianbo Wu, Doctorate

18560083793 jianbowu@126.com