Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate 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.
Condition or Disease
- Mediastinal Lymphadenopathies
- Mediastinal Masses
- Hilar Lymphadenopathies
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 149 (ACTUAL) |
| Funded by: | Other |
| Time Perspective: | Prospective |
Masking |
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Clinical Trial Dates
| Start date: | Nov 01, 2011 | |
|---|---|---|
| Primary Completion: | Jul 01, 2013 | ACTUAL |
| Completion Date: | Feb 01, 2014 | ACTUAL |
| Study First Posted: | Sep 09, 2011 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jul 22, 2015 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Healthy Volunteers: | Yes |
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
* 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
-
Diagnostic Yield 24 months
Secondary Outcomes
-
Complications rate 24 months
-
Time to recovery from anesthesia 24 months
-
Tolerance to procedure 24 months
More Details
| NCT Number: | NCT01430962 |
|---|---|
| Acronym: | EBUS-GA-MS |
| Other IDs: | H-27545 |
| Study URL: | https://clinicaltrials.gov/study/NCT01430962 |
Last updated: Sep 29, 2023