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Not yet recruiting NCT07637721

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

No phase Interventional Choledocholithiasis With Cholecystitis With Obstruction Obstructive Jaundice Pancreatitis Cholelithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group, The Regular Nasal Cannula.
Who it may be relevant to
Registry conditions: Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice, Pancreatitis, Cholelithiasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation：a Randomized Controlled Trial

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.

Interventions

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

Primary outcome measures

  • The incidence of hypoxia [Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)]
Secondary outcome measures (2)
  • The incidence of sub-clinical respiratory depression [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 [Time frame: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 3 centers
  • Tianjin Nankai Hospital, Tianjin Medical University — Tianjin
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • Shulan (Hangzhou) Hospital — Hangzhou

Identifiers

NCT: NCT07637721 · ZJU2025C221

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗