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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686656
• Other study ID #: tayfun1
• Status: Completed
• Phase: N/A
• Start date: December 24, 2020
• Est. completion date: April 6, 2021

Study information

• Verified date: December 2020
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 6, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Other:
• nasal oxygen
Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.
• buccal oxygen
Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.

Locations

Country	Name	City	State
Turkey	Antalya Training and Researching Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypoxia-related interruptions	the number of hypoxia-related interruptions	30 minutes
Secondary	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
Secondary	use of propofol	The use of amount of propofol will be noted during the procedure.	30 minutes
Secondary	use of fentanyl	The use of amount of fentanyl will be noted during the procedure.	30 minutes
Secondary	satisfaction of pulmonary specialist	satisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale	30 minutes