Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01430962
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Roberto Casal, Baylor College of Medicine

Tracking Information
First Submitted Date September 7, 2011
First Posted Date September 9, 2011
Last Update Posted Date July 23, 2015
Study Start Date November 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2011)
Diagnostic Yield [ Time Frame: 24 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 8, 2011)
  • Complications rate [ Time Frame: 24 months ]
  • Time to recovery from anesthesia [ Time Frame: 24 months ]
  • Tolerance to procedure [ Time Frame: 24 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult individuals with suspected mediastinal or hilar lymphadenopathies or masses referred for endobronchial ultrasound-guided biopsy.
Condition
  • Mediastinal Lymphadenopathies
  • Mediastinal Masses
  • Hilar Lymphadenopathies
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 22, 2015)
149
Original Estimated Enrollment
 (submitted: September 8, 2011)
200
Actual Study Completion Date February 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01430962
Other Study ID Numbers H-27545
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Roberto Casal, Baylor College of Medicine
Study Sponsor Baylor College of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Roberto F. Casal, MD Baylor College of Medicine- Michael E. DeBakey VA Medical Center
PRS Account Baylor College of Medicine
Verification Date July 2015