Status:
COMPLETED
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation
Lead Sponsor:
Baylor College of Medicine
Conditions:
Mediastinal Lymphadenopathies
Mediastinal Masses
Eligibility:
All Genders
18+ years
Brief Summary
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 bi...
Eligibility Criteria
Inclusion
- All patients over the age of 18, evaluated by pulmonary physician that require EBUS TBNA for sampling of hilar and/or mediastinal lymphadenopathies or masses
- Patients should be considered eligible to undergo either CS or GA, without contraindications for either one of them, based on the assessment by the pulmonologist who will perform EBUS-TBNA
Exclusion
- Pregnancy or breastfeeding women
- Patients deemed poor candidates for general anesthesia by the evaluating physician (e.g., severe coronary artery disease, COPD with FEV1 \< 1 liter, uncontrolled hypertension, increased intracranial pressure, reaction to anesthetics)
- Previous reaction to medications routinely used in conscious sedation
- Patients with history of intolerance to either general anesthesia or conscious sedation
- Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT01430962
Start Date
November 1 2011
End Date
February 1 2014
Last Update
July 23 2015
Active Locations (1)
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1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030