N/A
N=66
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
Bile Duct Carcinoma · Gallbladder Carcinoma · Pancreatic Ductal Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04740164 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants That Had Desaturation Episodes of SpO2 <90% — 0; 3; 26; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endoscopic Retrograde Cholangiopancreatography (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Had Desaturation Episodes of SpO2 <90% |
0; 3; 26; 27 | — |
| SECONDARY Incidence of Additional Airway Maneuvers |
5; 19; 21; 11 | — |
| SECONDARY Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support |
9; 10; 17; 20 | — |
| SECONDARY Incidence of Adverse Events |
24; 3 | — |
| SECONDARY To Evaluate Times Related to Anesthesia and Procedure |
75.0769; 62.8667; 32.6154; 45.5333 | — |
| SECONDARY To Evaluate Time From Procedure End to Anesthesia End |
18.5769; 11.2 | — |
| SECONDARY To Describe Heart Rates Within the Two Groups |
79.8846; 77.3667; 77.1154; 66.9667 | — |
| SECONDARY To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups |
127.2308; 137.5714; 122.0769; 128.2; 78.3462; 80.8571 | — |
| SECONDARY To Describe Oxygen Saturations Within the Two Groups |
98.5769; 99.033; 93.7692; 98.5 | — |
| SECONDARY To Evaluate Anesthesiologist Placing the Device |
77; 19; 4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04740164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.