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

Sponsor
Zhejiang University
Study ID
NCT07637721
Status
Not Yet Recruiting

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Conditions

  • Choledocholithiasis With Cholecystitis With Obstruction
  • Cholelithiasis
  • Obstructive Jaundice
  • Pancreatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group — DEVICE
    Patients received supraglottic oxygenation via an oral transtracheal catheter
  • The Regular Nasal Cannula — DEVICE
    Patients received oxygenation via the regular nasal cannula

Study Details

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.

Key Dates

First listed
Jun 10, 2026
Start date
Jun 12, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group
    In this group, patients received supraglottic oxygenation via an oral transtracheal catheter
  • Active Comparator: The Regular Nasal Cannula Group
    In this group, patients received oxygenation via the regular nasal cannula

Primary Outcome Measure

The incidence of hypoxia [ Time Frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit) ]

Central Contacts

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