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NCT Number: NCT07637721

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

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.

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Key information

Conditions

Choledocholithiasis With Cholecystitis With Obstruction Biliary Tract Diseases Cholelithiasis Digestive System Diseases Hyperbilirubinemia Hypoxia Jaundice Jaundice, Obstructive Obstructive Jaundice Pancreatic Diseases Pancreatitis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Nankai Hospital, Tianjin Medical University, Tianjin, Tianjin Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Primary outcomes

  1. The incidence of hypoxia

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

    75%≤SpO2<90%for<60s

Secondary outcomes

  1. 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)

    SpO2<75%or75%≤SpO2<90%for ≥60s

  2. 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)

    SpO2<75%or75%≤SpO2< 90%for≥60s

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su, PhD, MD

CONTACT

[email protected]

+8618616514088

Lianjuan Sun, Master

CONTACT

[email protected]

+8618257152767

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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