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The purpose of the study is to determine if there are any differences in yield or safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) (a type of bronchoscopy with biopsy) performed under general anesthesia versus moderate sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia | Patients will receive Total Intravenous Anesthesia (TIVA) with a combination of Propofol, Ketamine and neuromuscular blockade by anesthesia. Either an LMA or an ETT will be used to secure airway. | ||
| Moderate Sedation | Patients will receive moderate sedation given by the physician performing EBUS with a combination of Versed and Fentanyl per hospital protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Yield | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications rate | 24 months | |
| Time to recovery from anesthesia | 24 months | |
| Tolerance to procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Adult individuals with suspected mediastinal or hilar lymphadenopathies or masses referred for endobronchial ultrasound-guided biopsy.
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| Name | Affiliation | Role |
|---|---|---|
| Roberto F. Casal, MD | Baylor College of Medicine- Michael E. DeBakey VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20507652 | Background | Steinfort DP, Irving LB. Patient satisfaction during endobronchial ultrasound-guided transbronchial needle aspiration performed under conscious sedation. Respir Care. 2010 Jun;55(6):702-6. | |
| 16738038 | Background | Herth FJ, Eberhardt R, Vilmann P, Krasnik M, Ernst A. Real-time endobronchial ultrasound guided transbronchial needle aspiration for sampling mediastinal lymph nodes. Thorax. 2006 Sep;61(9):795-8. doi: 10.1136/thx.2005.047829. Epub 2006 May 31. |
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| 24 months |
| 21659432 | Background | Ost DE, Ernst A, Lei X, Feller-Kopman D, Eapen GA, Kovitz KL, Herth FJF, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration: results of the AQuIRE Bronchoscopy Registry. Chest. 2011 Dec;140(6):1557-1566. doi: 10.1378/chest.10-2914. Epub 2011 Jun 9. |
| 25574801 | Derived | Casal RF, Lazarus DR, Kuhl K, Nogueras-Gonzalez G, Perusich S, Green LK, Ost DE, Sarkiss M, Jimenez CA, Eapen GA, Morice RC, Cornwell L, Austria S, Sharafkanneh A, Rumbaut RE, Grosu H, Kheradmand F. Randomized trial of endobronchial ultrasound-guided transbronchial needle aspiration under general anesthesia versus moderate sedation. Am J Respir Crit Care Med. 2015 Apr 1;191(7):796-803. doi: 10.1164/rccm.201409-1615OC. |