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

NCT07637721 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-11-12
Last updated
2026-09-25

Condition(s) studied

Choledocholithiasis With Cholecystitis With ObstructionObstructive JaundicePancreatitisCholelithiasis

Investigational drug(s) / intervention(s)

The Supraglottic Oxygenation Via Oral Transtracheal Catheter GroupThe Regular Nasal Cannula

The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group: Patients received supraglottic oxygenation via an oral transtracheal catheter

The Regular Nasal Cannula: Patients received oxygenation via the regular nasal cannula

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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;

Primary outcome measure(s)

  • 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

Trial sites (3)

FacilityCityRegionStatus
Tianjin Nankai Hospital, Tianjin Medical University Tianjin Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
Shulan (Hangzhou) Hospital Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07637721 on ClinicalTrials.gov ↗ ← All trials in China