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In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capnography | Experimental | Arm with capnographic monitoring |
|
| Standard | Placebo Comparator | Standard monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capnography | Procedure | Capnographic monitoring |
| |
| Standard monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia | From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h |
| Measure | Description | Time Frame |
|---|---|---|
| Further complications | From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan von Delius, MD | Technical University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technische Universität München | Munich | Bavaria | 81675 | Germany | ||
| Knappschaftskrankenhaus der Ruhr-Universität Bochum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19422079 | Background | Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004. | |
| 26415090 |
| Label | URL |
|---|---|
| II. Medizinische Klinik der Technischen Universität München | View source |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Procedure |
Standard monitoring |
|
| Bochum |
| 44892 |
| Germany |
| Deutsche Klinik für Diagnostik | Wiesbaden | 65191 | Germany |
| Klare P, Reiter J, Meining A, Wagenpfeil S, Kronshage T, Geist C, Heringlake S, Schlag C, Bajbouj M, Schneider G, Schmid RM, Wehrmann T, von Delius S, Riphaus A. Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study). Endoscopy. 2016 Jan;48(1):42-50. doi: 10.1055/s-0034-1393117. Epub 2015 Sep 28. |