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NCT Number: NCT07012772

COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Other conditions deemed ineligible by investigators.

Treatment and study plan

the COMBO Endoscopy Oropharyngeal Airway

Device

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

Primary outcomes

  1. The incidence of hypoxia

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

    75% ≤ SpO2 < 90% for <60 s

Secondary outcomes

  1. The incidence of sub-clinical respiratory depression

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

    90% ≤ SpO2 < 95%

  2. The incidence of severe hypoxia

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

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

Other outcomes

  1. The incidence of other adverse events

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

DiSan Head of Anesthesiology, PhD

CONTACT

[email protected]

86+18616514088

Lianjuan Sun, Master

CONTACT

[email protected]

+8618257152767

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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