Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation

Completed

Conditions studied: Mediastinal Lymphadenopathies, Mediastinal Masses, Hilar Lymphadenopathies

In brief

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.

Key facts

Study ID

NCT01430962

Run by

Baylor College of Medicine

People needed

149

Starts

2011-11-01

Expected to finish

2014-02-01

Last updated by the study team

2015-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Michael E. DeBakey VA Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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