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2021-02-24
2023-05-04
2023-05-04
66
NCT04740164
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
INTERVENTIONAL
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
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.
PRIMARY OBJECTIVE: I. To compare the incidence of desaturation (oxygen saturation [SpO2] < 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula. SECONDARY OBJECTIVES: I. To evaluate the incidence of additional airway maneuvers (jaw thrust/chin lift/placement of oral airway or/nasal trumpet/intubation). II. To evaluate the incidence of withdrawal of duodenoscope from the airway to facilitate airway support. III. To evaluate the incidence of adverse events. IV. To evaluate times related to anesthesia and procedure (defined as Ȫnesthesia start to anesthesia end" and "procedure start to procedure end" respectively). V. 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]). VII. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-01-29 | 2024-04-23 | 2024-11-04 |
2021-02-04 | 2024-11-04 | 2024-11-06 |
2021-02-05 | 2024-11-06 | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Arm I (ERCP with LMA Gastro) Patients undergo ERCP with LMA Gastro. | PROCEDURE: Endoscopic Retrograde Cholangiopancreatography
|
| ACTIVE_COMPARATOR: Arm II (ERCP with standard nasal cannula) Patients undergo ERCP with standard nasal cannula. | PROCEDURE: Endoscopic Retrograde Cholangiopancreatography
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants That Had Desaturation Episodes of SpO2 <90% | The desaturation (SpO2 < 90%) between patients undergoing ERCP with LMA® Gastro™ vs standard nasal cannula | The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Additional Airway Maneuvers | Number of Participants that required additional manuevers to secure airway during their surgery | The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average |
| Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support | Patients in which Duodenoscope was withdrawn to facilitate airway support | The time between Anesthesia Start time and Anesthesia End time |
| Incidence of Adverse Events | Number of adverse events reported by the participants and/or reported by care providers during Surgery and in PACU, 3 hrs in average | From PACU arrival to PACU discharge, 3 hours in average |
| To Evaluate Times Related to Anesthesia and Procedure | Defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively | From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutes |
| To Evaluate Time From Procedure End to Anesthesia End | The time elapsed between procedure end and anesthesia end | From procedure end and anesthesia end, up to 60 minutes |
| To Describe Heart Rates Within the Two Groups | Heart rates were measured prior treatment administration and at the end of the procedure. | From "anesthesia start" to "anesthesia end", on average 5 hours |
| To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Blood pressure and end tidal carbon dioxide [CO2] were measured prior treatment administration and at the end of the procedure. | From "anesthesia start" to "anesthesia end", on average 5 hours |
| To Describe Oxygen Saturations Within the Two Groups | Oxygen saturations were measured prior treatment administration and at the end of the procedure. | From "anesthesia start" to "anesthesia end", on average 5 hours |
| To Evaluate Anesthesiologist Placing the Device | Number of attempts means how many times the anesthesiologist tried to secure airway. | At the end of procedure, between 5 - 10 minutes |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
