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RECRUITINGINTERVENTIONAL

The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure

The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18≤ Age ≤60. - Patients undergoing gastroendoscopy and/or colonoscopy procedure. - Patients have signed the willing to sign a consent form form. - The ASA classification ranges from I to II. - The estimated duration of the procedure does not exceed 45 minutes. Who Should NOT Join This Trial: - Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement. - Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs). - Profound renal insufficiency necessitating preoperative dialysis. - A confirmed severe liver dysfunction. - Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy. - Elevated intracranial pressure. - Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions. - Fever, defined as a core body temperature exceeding 37.5 degrees Celsius. - Pregnancy or lactation. - Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape. - Urgent surgical intervention. - Polytrauma. - Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively. - BMI\<18.5 or BMI\>30. - Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age 18≤ Age ≤60. * Patients undergoing gastroendoscopy and/or colonoscopy procedure. * Patients have signed the informed consent form. * The ASA classification ranges from I to II. * The estimated duration of the procedure does not exceed 45 minutes. Exclusion Criteria: * Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement. * Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs). * Profound renal insufficiency necessitating preoperative dialysis. * A confirmed severe liver dysfunction. * Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy. * Elevated intracranial pressure. * Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions. * Fever, defined as a core body temperature exceeding 37.5 degrees Celsius. * Pregnancy or lactation. * Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape. * Urgent surgical intervention. * Polytrauma. * Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively. * BMI\<18.5 or BMI\>30. * Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu. * Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis. * Presently engaged in concurrent participation in additional clinical trials. * Patients considered ineligible by researchers for inclusion in this clinical trial.

Treatments Being Tested

DEVICE

the COMBO Endoscopy Oropharyngeal Airway

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

DEVICE

Regular Nasal Cannula

Using regular nasal cannula for oxygenation.

Locations (10)

The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Shangdong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Renji Hospital
Shanghai, Shanghai Municipality, China
Tongji Hospital Of Tongji University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghia, China
The First Affliated Hospital of Xi'an Jiangtong University
Xi’an, Shanxi, China
Tianjin Mediacal University General Hospital
Tianjin, Tianjin Municipality, China
The First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China