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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Supraglottic Oxygen Delivery via an Endotracheal Tube

    Device

    patients use the Supraglottic Oxygen Delivery via an Endotracheal Tube

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Supraglottic Oxygen Delivery via an Endotracheal TubeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of hypoxia

75% ≤ SpO2 \< 90% for \<60 s

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

Secondary outcomes

1

The incidence of sub-clinical respiratory depression

90% ≤ SpO2 \< 95%

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

The incidence of severe hypoxia

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

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

Other outcomes

1

The incidence of other adverse events

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.