BridgeMD
New treatment option for Choledocholithiasis With Cholecystitis With Obstruction
Official title COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
ClinicalTrials.gov ID: NCT07012772
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join if
- Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion...
- 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;
See the full eligibility 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.
- 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 \ 30 kg/m²;
- Current participation in other clinical trials;
- Other conditions deemed ineligible by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.