Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation (EBUS-GA-MS)

• ClinicalTrials.gov Identifier: NCT01430962
• Recruitment Status: Completed
• First Posted: September 9, 2011
• Last Update Posted: July 23, 2015
• Sponsor: Baylor College of Medicine
• Information provided by (Responsible Party): Roberto Casal, Baylor College of Medicine

Study Description

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.

Condition or disease
Mediastinal Lymphadenopathies; Mediastinal Masses; Hilar Lymphadenopathies

Study Design

• Study Type: Observational
• Actual Enrollment: 149 participants
• Time Perspective: Prospective
• Official Title: Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation
• Study Start Date: November 2011
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: February 2014

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. Diagnostic Yield [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. Complications rate [ Time Frame: 24 months ]
2. Time to recovery from anesthesia [ Time Frame: 24 months ]
3. Tolerance to procedure [ Time Frame: 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult individuals with suspected mediastinal or hilar lymphadenopathies or masses referred for endobronchial ultrasound-guided biopsy.

Criteria

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

Contacts and Locations

Locations

United States, Texas

Michael E. DeBakey VA Medical Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

• Principal Investigator: Roberto F. Casal, MD; Baylor College of Medicine- Michael E. DeBakey VA Medical Center

More Information

Publications:

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.

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. Epub 2006 May 31.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Casal RF, Lazarus DR, Kuhl K, Nogueras-González 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.

• Responsible Party: Roberto Casal, Assistant Professor of Medicine, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT01430962
• Other Study ID Numbers: H-27545
• First Posted: September 9, 2011
• Last Update Posted: July 23, 2015
• Last Verified: July 2015

Keywords provided by Roberto Casal, Baylor College of Medicine:

EBUS; mediastinal lymph nodes; mediastinal masses; anesthesia; moderate sedation

Additional relevant MeSH terms:

Lymphadenopathy; Lymphatic Diseases