A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- To compare the incidence of desaturation (oxygen saturation [SpO2] < 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula.
SECONDARY OBJECTIVES:
-
To evaluate the incidence of additional airway maneuvers (jaw thrust/chin lift/placement of oral airway or/nasal trumpet/intubation).
-
To evaluate the incidence of withdrawal of duodenoscope from the airway to facilitate airway support.
-
To evaluate the incidence of adverse events. IV. To evaluate times related to anesthesia and procedure (defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively).
-
To evaluate time from procedure end to anesthesia end. VI. To describe hemodynamics within the two groups (recorded blood pressures, heart rates, oxygen saturations, and end tidal carbon dioxide [CO2]).
-
To evaluate anesthesiologist placing the device (training video viewed, number of practice attempts, years of experience).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo ERCP with LMA Gastro.
ARM II: Patients undergo ERCP with standard nasal cannula.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (ERCP with LMA Gastro) Patients undergo ERCP with LMA Gastro. |
Procedure: Endoscopic Retrograde Cholangiopancreatography
Undergo ERCP with LMA Gastro
Other Names:
|
| Active Comparator: Arm II (ERCP with standard nasal cannula) Patients undergo ERCP with standard nasal cannula. |
Procedure: Endoscopic Retrograde Cholangiopancreatography
Undergo ERCP with standard nasal cannula
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of desaturations (oxygen saturation [SpO2] < 90%) [Up to completion of endoscopic retrograde cholangiopancreatography]
Defined as at any time under sedation during procedure a patient has experienced at least one episode of desaturations. Fisher's exact test will be used to compare the percentage of patients with desaturations (SpO2 < 90%) between LMA Gastro and standard nasal cannula groups.
Secondary Outcome Measures
- Incidence of additional airway maneuvers [Up to completion of endoscopic retrograde cholangiopancreatography]
Will be summarized through frequencies and percentages.
- Incidence of adverse events [Up to completion of endoscopic retrograde cholangiopancreatography]
Will be summarized through frequencies and percentages.
- Incidence of withdrawal of duodenoscope from airway to facilitate airway support [Up to completion of endoscopic retrograde cholangiopancreatography]
Will be summarized through frequencies and percentages.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Katherine Hagan, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2020-1014
- NCI-2021-00118
- 2020-1014