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Recruiting NCT06081647

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

Trial Parameters

Condition Hypoxia
Sponsor RenJi Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,200
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2023-12-27
Completion 2025-12-27
Interventions
the COMBO Endoscopy Oropharyngeal AirwayRegular Nasal Cannula

Brief Summary

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.

Eligibility Criteria

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

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