Choledocholithiasis With Cholecystitis With Obstruction, Cholelithiasis, Obstructive Jaundice, Pancreatitis
Conditions
Keywords
ERCP, Monitored Anesthesia Care, deep sedation, hypoxemia, The Supraglottic Oxygenation Via Oral Transtracheal Catheter
Brief summary
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.
Interventions
DEVICEThe Supraglottic Oxygenation Via Oral Transtracheal Catheter Group
Patients received supraglottic oxygenation via an oral transtracheal catheter
DEVICEThe Regular Nasal Cannula
Patients received oxygenation via the regular nasal cannula
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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); * Confirmed pregnancy or current breastfeeding; * Hypersensitivity to sedative drugs such as propofol; * Current participation in other clinical trials;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypoxia | Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit) | 75%≤SpO2\<90%for\<60s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of sub-clinical respiratory depression | Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit) | SpO2\<75%or75%≤SpO2\<90%for ≥60s |
| The incidence of severe hypoxia | Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit) | SpO2\<75%or75%≤SpO2\< 90%for≥60s |
Countries
China
Contacts
CONTACTDiansan Su, PhD, MD
CONTACTLianjuan Sun, Master
Outcome results
None listed