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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04686656
Enrollment
60
Registered
2020-12-29
Start date
2020-12-24
Completion date
2021-04-06
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Brief summary

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

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.

Interventions

Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.

OTHERbuccal oxygen

Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
hypoxia-related interruptions30 minutesthe number of hypoxia-related interruptions

Secondary

MeasureTime frameDescription
duration of procedure30 minutesDuration of procedure will be defined in minute as the time from starting to insert EBUS device until the time to remove the device
use of propofol30 minutesThe use of amount of propofol will be noted during the procedure.
use of fentanyl30 minutesThe use of amount of fentanyl will be noted during the procedure.
satisfaction of pulmonary specialist30 minutessatisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026