About this trial
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) 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 this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
The ASA classification ranges from I to III.
Patients have signed the informed consent form.
Patients scheduled to undergo sedated ERCP examination;
Disqualifiers
Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;
Severe cardiac dysfunction (<4 METs);
Severe renal insufficiency (requiring preoperative dialysis);
Child-Pugh class C;
Trial design
Single group
Treatments tested in this trial
The COMBO Endoscopy Oropharyngeal Airway
DeviceUsing the COMBO Endoscopy Oropharyngeal Airway 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%
The incidence of severe hypoxia
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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