Supraglottic oxygen delivery through an endotracheal tube for ERCP under deep sedation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-stage Phase II feasibility and safety study conducted at a single tertiary center to test supraglottic oxygen delivery via an endotracheal tube during non-intubated ERCP performed under deep sedation. Adult patients (≥18 years) with ASA I–III scheduled for an ERCP expected to last ≤45 minutes will receive the supraglottic oxygen device during the procedure and be monitored for hypoxia and other adverse events. Key exclusions include significant cardiac or renal dysfunction, COPD or other chronic pulmonary disease requiring oxygen, BMI >30 kg/m², pregnancy or active upper respiratory infection. The protocol focuses on whether this airway adjunct reduces the incidence of desaturation and is safe and feasible in this setting.

Why it matters

Who can join: the full rules

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;

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: DiSan Head of Anesthesiology, PhD
• Email: diansansu@yahoo.com
• Phone: +86 18616514088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.