Effect of Nasopharyngeal Airway-Assisted Deep Sedation vs. Endotracheal Intubation General Anesthesia on Respiratory Complications During ERCP

Launched by GANG CHEN · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring two methods of sedation used during a specific procedure called Endoscopic Retrograde Cholangiopancreatography (ERCP), which is often done to treat issues related to bile ducts and the pancreas. The study will compare using a nasopharyngeal airway-assisted deep sedation—where a small tube is placed in the nose to help with breathing—against general anesthesia, where a breathing tube is inserted into the throat. The goal is to see which method results in fewer breathing-related problems during and after the procedure.

To participate in this study, individuals must be at least 18 years old and have a specific health status defined by the American Society of Anesthesiologists, which generally indicates they are in stable health (levels 1 to 3). Participants will be those needing an elective ERCP and who willingly agree to take part in the study, signing an informed consent form. However, there are certain conditions that would exclude someone from participating, such as serious heart or lung diseases, recent infections, or certain anatomical issues with the stomach. This trial is not yet recruiting participants, but it's important for potential volunteers to understand these criteria and what to expect if they decide to join.

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Eligibility criteria

• • Inclusion criteria：
• • 1. ≥ 18 years old
• • 2. American Society of Anesthesiologists classification (ASA) 1-3.
• • 3. Patients who require elective ERCP
• • 4. Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of capacity, their guardian needs to act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.
• • Exclusion criteria：
• • 1. Altered gastrointestinal anatomy, delayed gastric emptying, or gastric outlet obstruction
• • 2. Coagulopathy or epistaxis tendency
• • 3. Cardiac diseases (e.g., coronary artery disease, heart failure, arrhythmias)
• • 4. Pulmonary diseases (e.g., asthma, COPD)
• • 5. Prior hypersensitivity to anesthetic agents
• • 6. Active upper respiratory infection
• • 7. Hepatic/renal dysfunction
• • 8. Difficult airway (e.g., severe OSA)
• • 9. Psychiatric disorders, cognitive impairment, critical illness, or pregnancy