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

Completed

• Conditions: Mediastinal Masses; Mediastinal Lymphadenopathies; Hilar Lymphadenopathies

• Registration Number: NCT01430962
• Lead Sponsor: Baylor College of Medicine

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 biopsy) performed under general anesthesia versus moderate sedation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Study Start: 2011-11
• Primary Completion: 2013-07
• Study Completion: 2014-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Yield	24 months

Secondary Outcome Measures

Name	Time	Method
Time to recovery from anesthesia	24 months
Complications rate	24 months
Tolerance to procedure	24 months

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States