A Phase 2 interventional study of The COMBO Endoscopy Oropharyngeal Airway in Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice and Pancreatitis, sponsored by Zhejiang University. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Zhejiang University · Phase 2, Interventional, and Prevention
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.
62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.
This study's planned enrollment of 50 is below the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →Zhejiang University is the lead sponsor of 356 studies on the registry; 166 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Device: The COMBO Endoscopy Oropharyngeal Airway
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
The incidence of hypoxia
75% ≤ SpO2 \< 90% for \<60 s
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 \< 95%
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Sep 2025, 3 months after the start.
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