Clinical trial NCT07012772: COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
Official title: COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Choledocholithiasis With Cholecystitis With Obstruction
Obstructive Jaundice
Pancreatitis
Cholelithiasis
Keywords: respiratory depression
The COMBO Endoscopy Oropharyngeal Airway
Hypoxia
Sedation
ERCP
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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:

1. Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;
2. Severe cardiac dysfunction (\<4 METs);
3. Severe renal insufficiency (requiring preoperative dialysis);
4. Child-Pugh class C;
5. Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
6. Increased intracranial pressure;
7. Upper respiratory tract infections (oral/nasal/pharyngeal);
8. Fever (core temperature \>37.5°C);
9. Confirmed pregnancy or current breastfeeding;
10. Allergy to sedatives (e.g., propofol) or medical adhesives;
11. Emergency procedures;
12. Multiple trauma injuries;
13. Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively;
14. BMI \<18.5 or \>30 kg/m²;
15. Current participation in other clinical trials;
16. Other conditions deemed ineligible by investigators.

Primary outcomes:
measure: The incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary outcomes:
measure: The incidence of sub-clinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
measure: The incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other outcomes:
measure: The incidence of other adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Locations:
city: HangZhou
country: China
facility: The First Affiliated Hospital,Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: