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OpenTrials
Completed

NCT Number: NCT01430962

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic Yield

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation

Acronym: EBUS-GA-MS

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Sep 9, 2011
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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