Nasal Versus Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Study Overview
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Brief Summary
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The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .

Detailed Description
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Anesthesia for Endobronchial Ultrasound (EBUS) may be range from routine bronchoscopy sedation to general anesthesia. During sedation to EBUS increased duration of anesthesia and sedative dosing put patients at increased risk for hypoxic events. To avoid this, oxygen supplementation is mandatory. There are different techniques for oxygen supplementation during the procedure. At this study we will compare to nasal and buccal oxygen supplementations during EBUS.

Official Title
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A Randomized Controlled Trial Comparing Nasal With Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Conditions
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Lung Diseases

Intervention / Treatment
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* Other: nasal oxygen
* Other: buccal oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients ≥18 years of age body mass index (BMI) between 20 and 30 American Society of Anesthesiologists physical status I-III Exclusion Criteria: congestive heart failure ischemic heart disease increased intracranial pressure known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam) an anatomical feature precluding adequate positioning of the buccal device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nasal oxygen supplementation group<br>supplemental oxygen will be administered with nasal cannula | Other: nasal oxygen<br>* Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.<br>|
| Active Comparator: buccal oxygen supplementation group<br>supplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube | Other: buccal oxygen<br>* Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoxia-related interruptions | the number of hypoxia-related interruptions | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of procedure | Duration of procedure will be defined in minute as the time from starting to insert EBUS device until the time to remove the device | 30 minutes | 
| use of propofol | The use of amount of propofol will be noted during the procedure. | 30 minutes | 
| use of fentanyl | The use of amount of fentanyl will be noted during the procedure. | 30 minutes | 
| satisfaction of pulmonary specialist | satisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale | 30 minutes |