About this trial
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. This is particularly true for obese patients, who have a higher incidence of hypoxia. 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 this study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18≤ Age ≤70.
BMI ≥ 28 kg/m².
The ASA classification ranges from I to II.
Patients have signed the informed consent form.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
the COMBO Endoscopy Oropharyngeal Airway Group
DeviceUsing the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Regular Nasal Cannula
DeviceUsing regular nasal cannula for oxygenation.
Treatment groups
Trial outcomes
Primary outcomes
The incidence of hypoxia
75% ≤ SpO2 \< 90% for \<60 s
Secondary outcomes
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 \< 95%
SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s
SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s
Other outcomes
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Sponsors and contacts
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