About this trial
Endoscopic retrograde cholangiopancreatography (ERCP) is a technique for evaluating the bile duct, pancreatic duct, and ampulla. Hypoxia is the most common cardiopulmonary complication during ERCP, with a reported rate of 16.2 to 39.2%. The key to preventing hypoxia is to ensure the sufficient oxygenation and ventilation of patients during these procedures. The commonly used approaches to treat hypoxia with a non-instrumented airway are increasing the oxygen flow and lifting the jaw, applying with both hands, displacing the jaw upwards and anteriorly, which allowed the upper airway to remain open. We hypothesized that the supraglottic oxygen delivery via an endotracheal tube can reduce the incidence of hypoxia in patients under deep sedation during ERCP.
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
Severe cardiac dysfunction (<4 METs);
Severe renal insufficiency (requiring preoperative dialysis);
Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
Increased intracranial pressure;
Trial design
Single group
Treatments tested in this trial
Supraglottic Oxygen Delivery via an Endotracheal Tube
Devicepatients use the Supraglottic Oxygen Delivery via an Endotracheal Tube
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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