Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation

N/ANot Yet RecruitingNCT07637721

Zhejiang University410 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

410

Conditions

Choledocholithiasis With Cholecystitis With Obstruction Obstructive Jaundice Pancreatitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (3)

Tianjin Nankai Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

The incidence of hypoxia

75%≤SpO2\<90%for\<60s

Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)

Secondary Outcomes

The incidence of sub-clinical respiratory depression

SpO2\<75%or75%≤SpO2\<90%for ≥60s

Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)

The incidence of severe hypoxia

SpO2\<75%or75%≤SpO2\< 90%for≥60s

Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)

Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts