- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01430962
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation (EBUS-GA-MS)
July 22, 2015 updated by: Roberto Casal, Baylor College of Medicine
Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult individuals with suspected mediastinal or hilar lymphadenopathies or masses referred for endobronchial ultrasound-guided biopsy.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnostic Yield
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications rate
Time Frame: 24 months
|
24 months
|
Time to recovery from anesthesia
Time Frame: 24 months
|
24 months
|
Tolerance to procedure
Time Frame: 24 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roberto F. Casal, MD, Baylor College of Medicine- Michael E. DeBakey VA Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
September 7, 2011
First Submitted That Met QC Criteria
September 8, 2011
First Posted (Estimate)
September 9, 2011
Study Record Updates
Last Update Posted (Estimate)
July 23, 2015
Last Update Submitted That Met QC Criteria
July 22, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-27545
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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