COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The COMBO Endoscopy Oropharyngeal Airway.
- Who it may be relevant to
- Registry conditions: Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice, Pancreatitis, Cholelithiasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device The COMBO Endoscopy Oropharyngeal Airway
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Primary outcome measures
- The incidence of hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Secondary outcome measures (2)
- 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]
- The incidence of severe hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 2 centers
- he First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
- The First Affiliated Hospital,Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07012772 · ZJU2025B0632