Clinical trial NCT01430962: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation
Official title: Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mediastinal Lymphadenopathies
Mediastinal Masses
Hilar Lymphadenopathies
Keywords: EBUS
mediastinal lymph nodes
mediastinal masses
anesthesia
moderate sedation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals with suspected mediastinal or hilar lymphadenopathies or masses referred for endobronchial ultrasound-guided biopsy.

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.


Eligibility 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

Primary outcomes:
measure: Diagnostic Yield
timeFrame: 24 months
Secondary outcomes:
measure: Complications rate
timeFrame: 24 months
measure: Time to recovery from anesthesia
timeFrame: 24 months
measure: Tolerance to procedure
timeFrame: 24 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine- Michael E. DeBakey VA Medical Center
name: Roberto F. Casal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.