Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for the diagnosis and treatment of pancreatobiliary diseases. While Monitored Anesthesia Care (MAC) enhances the efficiency of ERCP, deep sedation introduces significant airway risks, particularly hypoxemia resulting from sedative-induced upper airway collapse. With reported hypoxemia rates ranging from 10% to 69%, and the potential for severe complications such as myocardial ischemia and neurological damage, effective airway management is paramount. Supraglottic oxygenation via oral transtracheal catheter provides a viable method for relieving obstruction and enabling positive pressure ventilation, serving as a less invasive alternative to tracheal intubation. Despite its proven utility in other settings, this technique has not yet been evaluated in the context of deeply sedated ERCP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18years

The ASA classification ranges from I to III

Patients have signed the informed consent form

Patients scheduled to undergo sedated ERCP examination procedure

Disqualifiers

Severe cardiac dysfunction (<4 METs);

Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;

Upper respiratory tract infections including oral, nasal or pharyngeal infections;

Fever (core temperature >37.5°C);

Trial design

Design model

Parallel

Treatments tested in this trial

  • The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group

    Device

    Patients received supraglottic oxygenation via an oral transtracheal catheter

  • The Regular Nasal Cannula

    Device

    Patients received oxygenation via the regular nasal cannula

Treatment groups

410 Participants
are divided into 2 treatment groups
Group A: The Supraglottic Oxygenation Via Oral Transtracheal Catheter GroupExperimental treatment 1 intervention
Group B: The Regular Nasal Cannula GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of hypoxia

75%≤SpO2\<90%for\<60s

Time frame
Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)

Secondary outcomes

1

The incidence of sub-clinical respiratory depression

90%\</=SpO2\<95%

Time frame
Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
2

The incidence of severe hypoxia

SpO2\<75%or75%≤SpO2\< 90%for≥60s

Time frame
Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)

Other outcomes

Sponsors and contacts

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