NCT07637721

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

May 19, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

June 12, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

May 19, 2026

Last Update Submit

June 9, 2026

Conditions

Choledocholithiasis With Cholecystitis With ObstructionObstructive JaundicePancreatitisCholelithiasis

Keywords

ERCPMonitored Anesthesia Caredeep sedationhypoxemiaThe Supraglottic Oxygenation Via Oral Transtracheal Catheter

Outcome Measures

Primary Outcomes (1)

  • The incidence of hypoxia

    75%≤SpO2\<90%for\<60s

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

Secondary Outcomes (2)

  • The incidence of sub-clinical respiratory depression

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

  • The incidence of severe hypoxia

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

Study Arms (2)

The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group

EXPERIMENTAL

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

Device: The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group

The Regular Nasal Cannula Group

ACTIVE COMPARATOR

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

Device: The Regular Nasal Cannula

Interventions

The Supraglottic Oxygenation Via Oral Transtracheal Catheter GroupDEVICE

Patients received supraglottic oxygenation via an oral transtracheal catheter

The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group
The Regular Nasal CannulaDEVICE

Patients received oxygenation via the regular nasal cannula

The Regular Nasal Cannula Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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);
  • Confirmed pregnancy or current breastfeeding;
  • Hypersensitivity to sedative drugs such as propofol;
  • Current participation in other clinical trials;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tianjin Nankai Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, 300100, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, 310011, China

Location

MeSH Terms

Conditions

Jaundice, ObstructivePancreatitisCholelithiasisHypoxia

Condition Hierarchy (Ancestors)

JaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsPancreatic DiseasesDigestive System DiseasesBiliary Tract DiseasesSigns and Symptoms, Respiratory

Central Study Contacts

Diansan Su, PhD, MD

CONTACT

+8618616514088diansansu@yahoo.com

Lianjuan Sun, Master

CONTACT

+8618257152767sunlianjuan26@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Anesthesiology

Study Record Dates

First Submitted

May 19, 2026

First Posted

June 10, 2026

Study Start

June 12, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations

CN(3)