Clinical trial · Interventional
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
A Randomized Study to Compare LMA® Gastro™, a Dual Channel Supraglottic Airway (SGA) Device, to Oxygenation With Standard Nasal Cannula for Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Carcinoma | Cholangiocarcinoma | ALIAS | 0.90 |
| Gallbladder Carcinoma | Gallbladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (ERCP with LMA Gastro)
- description
- Patients undergo ERCP with LMA Gastro.
- interventionNames
- Procedure: Endoscopic Retrograde Cholangiopancreatography
- type
- ACTIVE_COMPARATOR
- label
- Arm II (ERCP with standard nasal cannula)
- description
- Patients undergo ERCP with standard nasal cannula.
- interventionNames
- Procedure: Endoscopic Retrograde Cholangiopancreatography
Primary outcomes (1)
- measure
- Number of Participants That Had Desaturation Episodes of SpO2 <90%
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>= 18 years old) undergoing ERCP Exclusion Criteria: * Patients with propofol allergy * Patients at increased aspiration risk * Patients with abnormal head/neck pathology preventing LMA Gastro placement * Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult * Patient with known difficult airway requiring advanced intubation equipment (with the exception of the video-laryngoscope) in the past * Esophagectomy patients * Patients already intubated upon arrival to endoscopy suite * Patients undergoing endoscopic ultrasound (EUS) * Patients with body mass index (BMI) \>= 35 kg/m\^2 * Patients with hypoxemia (SpO2 \< 94% on room air or on home oxygen) * American Society of Anesthesiology (ASA) Physical Status IV-V
References
Publications (0)
Data not yet available