About this trial
Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for the diagnosis and treatment of pancreatobiliary diseases. While Monitored Anesthesia Care (MAC) enhances the efficiency of ERCP, deep sedation introduces significant airway risks, particularly hypoxemia resulting from sedative-induced upper airway collapse. With reported hypoxemia rates ranging from 10% to 69%, and the potential for severe complications such as myocardial ischemia and neurological damage, effective airway management is paramount. Supraglottic oxygenation via oral transtracheal catheter provides a viable method for relieving obstruction and enabling positive pressure ventilation, serving as a less invasive alternative to tracheal intubation. Despite its proven utility in other settings, this technique has not yet been evaluated in the context of deeply sedated ERCP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18years
The ASA classification ranges from I to III
Patients have signed the informed consent form
Patients scheduled to undergo sedated ERCP examination procedure
Disqualifiers
Severe cardiac dysfunction (<4 METs);
Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
Upper respiratory tract infections including oral, nasal or pharyngeal infections;
Fever (core temperature >37.5°C);
Trial design
Parallel
Treatments tested in this trial
The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group
DevicePatients received supraglottic oxygenation via an oral transtracheal catheter
The Regular Nasal Cannula
DevicePatients received oxygenation via the regular nasal cannula
Treatment groups
Trial outcomes
Primary outcomes
The incidence of hypoxia
75%≤SpO2\<90%for\<60s
Secondary outcomes
The incidence of sub-clinical respiratory depression
90%\</=SpO2\<95%
The incidence of severe hypoxia
SpO2\<75%or75%≤SpO2\< 90%for≥60s
Sponsors and contacts
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