ClinicalTrials.gg
Not yet recruitingNCT07637721Updated Sep 25, 2026

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

An interventional study of The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group and The Regular Nasal Cannula in Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice and Pancreatitis, sponsored by Zhejiang University. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Zhejiang University · Not applicable, Interventional, and Prevention

Updated Sep 25, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Choledocholithiasis With Cholecystitis With Obstruction
  • Obstructive Jaundice
  • Pancreatitis
  • Cholelithiasis

Keywords

  • ERCP
  • Monitored Anesthesia Care
  • deep sedation
  • hypoxemia
  • The Supraglottic Oxygenation Via Oral Transtracheal Catheter
03

In context

Jaundice, Obstructive

62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.

This study's planned enrollment of 410 is above the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.

Browse Jaundice, Obstructive studies →

Lead sponsor

Zhejiang University is the lead sponsor of 356 studies on the registry; 166 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age≥18years
  • The ranges from I to III
  • Patients have signed the form
  • Patients scheduled to undergo sedated ERCP examination procedure

Exclusion criteria

Exclusion Criteria:

  • Severe cardiac dysfunction (\<4 METs);
  • Diagnosed (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);
  • Confirmed pregnancy or current breastfeeding;
  • to sedative drugs such as propofol;
  • Current participation in other clinical trials;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group

    In this group, patients received supraglottic oxygenation via an oral transtracheal catheter

    Device: The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group

  • Active comparator
    The Regular Nasal Cannula Group

    In this group, patients received oxygenation via the regular nasal cannula

    Device: The Regular Nasal Cannula

Interventions

  • DeviceThe Supraglottic Oxygenation Via Oral Transtracheal Catheter Group

    Patients received supraglottic oxygenation via an oral transtracheal catheter

  • DeviceThe Regular Nasal Cannula

    Patients received oxygenation via the regular nasal cannula

06

What researchers measure

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)

07

Study locations

3 sites
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Jun 12, 2026→Nov 12, 2026
Sep 25, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionThe incidence of sub-clinical respiratory depression: how it is measured was reworded
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Start date Jun 12, 2026→Nov 12, 2026
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionThe incidence of sub-clinical respiratory depression: how it is measured was reworded
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07637721
Responsible party
Diansan Su (Chairman of Anesthesiology, Zhejiang University) — Principal investigator
First posted
Jun 10, 2026
Start date
Nov 12, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Diansan Su, PhD, MD
Contact
diansansu@yahoo.com
+8618616514088
Lianjuan Sun, Master
Contact
sunlianjuan26@163.com
+8618257152767

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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