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

Not Applicable

Completed

• Conditions: Lung Diseases
• Interventions: Other: nasal oxygen; Other: buccal oxygen

• Registration Number: NCT04686656
• Lead Sponsor: Antalya Training and Research Hospital

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Study Start: 2020-12-24
• Study First Posted: 2020-12-29
• Primary Completion: 2021-02-24
• Study Completion: 2021-04-06
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nasal oxygen supplementation group	nasal oxygen	supplemental oxygen will be administered with nasal cannula
buccal oxygen supplementation group	buccal oxygen	supplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube

Primary Outcome Measures

Name	Time	Method
hypoxia-related interruptions	30 minutes	the number of hypoxia-related interruptions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Antalya Training and Researching Hospital; 🇹🇷 Antalya, Turkey