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

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

This tests whether delivering oxygen just above the vocal cords through an endotracheal tube can prevent low oxygen levels in adults having ERCP with deep sedation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07051980 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with ASA I–III who are scheduled for a sedated ERCP expected to last ≤45 minutes and who do not have severe cardiac, renal, or pulmonary disease and have BMI ≤30 kg/m².

Not a fit: Patients with COPD or other chronic pulmonary disease requiring oxygen, BMI >30 kg/m², severe cardiac or renal dysfunction, pregnancy or breastfeeding, active upper respiratory infections or fever, or those currently in other clinical trials are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could reduce episodes of hypoxia during ERCP under deep sedation and lower cardiopulmonary complications.

How similar studies have performed: High-flow nasal oxygen and nasopharyngeal oxygenation have shown benefit in reducing desaturation during sedation, but using supraglottic oxygen delivery via an endotracheal tube for non-intubated ERCP is a relatively novel approach with limited prior testing.

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;

Where this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: DiSan Head of Anesthesiology, PhD

Conditions Choledocholithiasis With Cholecystitis With Obstruction; Obstructive Jaundice; Pancreatitis; Cholelithiasis; ERCP; respiratory depression; Hypoxia; Sedation