NCT07012772

Brief Summary

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
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

First Submitted

Initial submission to the registry

May 27, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 27, 2025

Last Update Submit

June 23, 2025

Conditions

Choledocholithiasis With Cholecystitis With ObstructionObstructive JaundicePancreatitisCholelithiasis

Keywords

respiratory depressionThe COMBO Endoscopy Oropharyngeal AirwayHypoxiaSedationERCP

Outcome Measures

Primary Outcomes (1)

  • The incidence of hypoxia

    75% ≤ SpO2 \< 90% for \<60 s

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

Secondary Outcomes (2)

  • The incidence of sub-clinical respiratory depression

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

  • The incidence of severe hypoxia

    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

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

Study Arms (1)

The COMBO Endoscopy Oropharyngeal Airway Group

EXPERIMENTAL

In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Device: The COMBO Endoscopy Oropharyngeal Airway

Interventions

The COMBO Endoscopy Oropharyngeal AirwayDEVICE

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

The COMBO Endoscopy Oropharyngeal Airway Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;
  • Severe cardiac dysfunction (\<4 METs);
  • Severe renal insufficiency (requiring preoperative dialysis);
  • Child-Pugh class C;
  • 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;
  • Emergency procedures;
  • Multiple trauma injuries;
  • Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively;
  • BMI \<18.5 or \>30 kg/m²;
  • Current participation in other clinical trials;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

he First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Jaundice, ObstructivePancreatitisCholelithiasisRespiratory InsufficiencyHypoxia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

DiSan Head of Anesthesiology, PhD

CONTACT

86+18616514088184872238@qq.com

Lianjuan Sun, Master

CONTACT

+8618257152767sunlianjuan26@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Department of Anesthesiology

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 10, 2025

Study Start

June 12, 2025

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations

CN(2)