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

Primary Purpose

Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
nasal oxygen
buccal oxygen
Sponsored by
Antalya Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Diseases

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Antalya Training and Researching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

nasal oxygen supplementation group

buccal oxygen supplementation group

Arm Description

supplemental oxygen will be administered with nasal cannula

supplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube

Outcomes

Primary Outcome Measures

hypoxia-related interruptions
the number of hypoxia-related interruptions

Secondary Outcome Measures

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
use of propofol
The use of amount of propofol will be noted during the procedure.
use of fentanyl
The use of amount of fentanyl will be noted during the procedure.
satisfaction of pulmonary specialist
satisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale

Full Information

First Posted
December 23, 2020
Last Updated
April 6, 2021
Sponsor
Antalya Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04686656
Brief Title
Nasal Versus Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Official Title
A Randomized Controlled Trial Comparing Nasal With Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 24, 2020 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nasal oxygen supplementation group
Arm Type
Active Comparator
Arm Description
supplemental oxygen will be administered with nasal cannula
Arm Title
buccal oxygen supplementation group
Arm Type
Active Comparator
Arm Description
supplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube
Intervention Type
Other
Intervention Name(s)
nasal oxygen
Intervention Description
Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.
Intervention Type
Other
Intervention Name(s)
buccal oxygen
Intervention Description
Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.
Primary Outcome Measure Information:
Title
hypoxia-related interruptions
Description
the number of hypoxia-related interruptions
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
duration of procedure
Description
Duration of procedure will be defined in minute as the time from starting to insert EBUS device until the time to remove the device
Time Frame
30 minutes
Title
use of propofol
Description
The use of amount of propofol will be noted during the procedure.
Time Frame
30 minutes
Title
use of fentanyl
Description
The use of amount of fentanyl will be noted during the procedure.
Time Frame
30 minutes
Title
satisfaction of pulmonary specialist
Description
satisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tayfun sugur, MD
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Researching Hospital
City
Antalya
Country
Turkey

12. IPD Sharing Statement

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

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