Choledocholithiasis With Cholecystitis With Obstruction, Cholelithiasis, Obstructive Jaundice, Pancreatitis
Conditions
Keywords
ERCP, respiratory depression, Hypoxia, Sedation
Brief summary
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.
Interventions
DEVICESupraglottic Oxygen Delivery via an Endotracheal Tube
patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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; * The estimated duration of the procedure does not exceed 45 minutes.
Exclusion criteria
* 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; * Upper respiratory tract infections (oral/nasal/pharyngeal); * Fever (core temperature \>37.5°C); * Confirmed pregnancy or current breastfeeding; * Allergy to sedatives (e.g., propofol) or medical adhesives; * BMI \>30 kg/m²; * Current participation in other clinical trials;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 75% ≤ SpO2 \< 90% for \<60 s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of sub-clinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 90% ≤ SpO2 \< 95% |
| The incidence of severe hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s |
Other
| Measure | Time frame | Description |
|---|---|---|
| The incidence of other adverse events | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force |
Countries
China
Contacts
Primary ContactDiSan Head of Anesthesiology, PhD
Backup ContactLianjuan Sun, Master
Outcome results
None listed