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

Gang Chen

Status: Not yet enrolling

Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP); Biliary and Pancreatic Diseases

Treatments: Device: Nasopharyngeal airway ventilation; Device: Tracheal intubation general anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07017283

ERCP

Details and patient eligibility

About

This study aims to investigate the impact of nasopharyngeal airway-assisted deep sedation versus endotracheal intubation general anesthesia on perioperative respiratory adverse events during ERCP.

Full description

This study aims to investigate the impact of nasopharyngeal airway-assisted deep sedation versus endotracheal intubation general anesthesia on perioperative respiratory adverse events during ERCP.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

General anesthesia

Active Comparator group

Treatment:

Device: Tracheal intubation general anesthesia

Nasopharyngeal airway assists deep sedation

Experimental group

Treatment:

Device: Nasopharyngeal airway ventilation