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

This study is currently recruiting participants.

Verified October 2011 by Baylor College of Medicine

Sponsor:

Information provided by (Responsible Party):

Roberto Casal, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT01430962

First received: September 7, 2011

Last updated: October 24, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2011

Last Updated Date

October 24, 2011

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Diagnostic Yield [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01430962 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Complications rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Time to recovery from anesthesia [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Tolerance to procedure [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Mediastinal Lymphadenopathies
Mediastinal Masses
Hilar Lymphadenopathies

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Not Provided

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Roberto F. Casal, MD

713-794-8066

casal@bcm.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01430962

Other Study ID Numbers ^ICMJE

H-27545

Has Data Monitoring Committee

Responsible Party

Roberto Casal, Baylor College of Medicine

Study Sponsor ^ICMJE

Baylor College of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Roberto F. Casal, MD

Baylor College of Medicine- Michael E. DeBakey VA Medical Center

Information Provided By

Baylor College of Medicine

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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