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The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and the effect on airway complications (problems), time to biliary cannulation (access into bile duct) and total procedure duration (length of time). Two methods are being compared and studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation: local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| general endotracheal anesthesia | Active Comparator | an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose |
|
| deep sedation without endotracheal intubation | Active Comparator | local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| general endotracheal anesthesia | Other | sedation with the use of endotracheal intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sedation related adverse events or the need for airway maneuvers | approximately one year |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | intraoperative | |
| Time to cannulation of intended duct system | during the procedure | |
| Technical success of ERCP |
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Inclusion Criteria:
Patient undergoing ERCP without preceding endoscopic ultrasound (EUS)
At least one of the following risk factors for adverse events during sedation:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine in St Louis | St Louis | Missouri | 63010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30217726 | Derived | Smith ZL, Mullady DK, Lang GD, Das KK, Hovis RM, Patel RS, Hollander TG, Elsner J, Ifune C, Kushnir VM. A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients. Gastrointest Endosc. 2019 Apr;89(4):855-862. doi: 10.1016/j.gie.2018.09.001. Epub 2018 Sep 11. |
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| ID | Term |
|---|---|
| D054810 | Deep Sedation |
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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| deep sedation without endotracheal intubation | Other | deep sedation without endotracheal airway management. |
|
|
| approximately one year |
| Immediate ERCP adverse events | Adverse events within 24 hours of ERCP |
| Delayed adverse events | Adverse events occurring within 7 days |
| D008919 |
| Investigative Techniques |