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Recruiting NCT07051980

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

Phase II 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: Supraglottic Oxygen Delivery via an Endotracheal Tube.
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 →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Supraglottic Oxygen Delivery via an Endotracheal Tube
    patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube

Primary outcome measures

  • The incidence of hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Secondary outcome measures (2)
  • 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]
  • The incidence of severe hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Eligibility criteria

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;

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07051980 · ZJU2025B0679

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗