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NCT Number: NCT07051980

Feasibility and Safety of Supraglottic Oxygen Delivery Via an Endotracheal Tube for Non-intubated ERCP Anesthesia: A Two-Stage Phase II Clinical Study

Endoscopic retrograde cholangiopancreatography (ERCP) is a technique for evaluating the bile duct, pancreatic duct, and ampulla. Hypoxia is the most common cardiopulmonary complication during ERCP, with a reported rate of 16.2 to 39.2%. The key to preventing hypoxia is to ensure the sufficient oxygenation and ventilation of patients during these procedures. The commonly used approaches to treat hypoxia with a non-instrumented airway are increasing the oxygen flow and lifting the jaw, applying with both hands, displacing the jaw upwards and anteriorly, which allowed the upper airway to remain open. We hypothesized that the supraglottic oxygen delivery via an endotracheal tube can reduce the incidence of hypoxia in patients under deep sedation during 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 Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

DiSan Diansan Su, PhD

CONTACT

[email protected]

+86 18616514088

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years；
  • The ASA classification ranges from I to III.
  • Patients have signed the informed consent form.
  • Patients scheduled to undergo sedated ERCP examination;
  • The estimated duration of the procedure does not exceed 45 minutes.

Exclusion criteria

  • Severe cardiac dysfunction (<4 METs);
  • Severe renal insufficiency (requiring preoperative dialysis);
  • Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
  • Increased intracranial pressure;
  • Upper respiratory tract infections (oral/nasal/pharyngeal);
  • Fever (core temperature >37.5°C);
  • Confirmed pregnancy or current breastfeeding;
  • Allergy to sedatives (e.g., propofol) or medical adhesives;
  • BMI >30 kg/m²;
  • Current participation in other clinical trials;

Treatment and study plan

Supraglottic Oxygen Delivery via an Endotracheal Tube

Device

patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube

Primary outcomes

  1. The incidence of hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    75% ≤ SpO2 < 90% for <60 s

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    90% ≤ SpO2 < 95%

  2. The incidence of severe hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s

Other outcomes

  1. The incidence of other adverse events

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Study contacts

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

DiSan Head of Anesthesiology, PhD

CONTACT

[email protected]

+86 18616514088

Lianjuan Sun, Master

CONTACT

[email protected]

+86 18257152767

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 4, 2025
Registry last updated
Jul 17, 2025

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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