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

April 6, 2021 updated by: Antalya Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Antalya Training and Researching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: nasal oxygen supplementation group
supplemental oxygen will be administered with nasal cannula
Other: nasal oxygen
Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.
ACTIVE_COMPARATOR: buccal oxygen supplementation group
supplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of procedure
Time Frame: 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
30 minutes
use of propofol
Time Frame: 30 minutes
The use of amount of propofol will be noted during the procedure.
30 minutes
use of fentanyl
Time Frame: 30 minutes
The use of amount of fentanyl will be noted during the procedure.
30 minutes
satisfaction of pulmonary specialist
Time Frame: 30 minutes
satisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Principal Investigator: tayfun sugur, MD, Antalya Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 24, 2020

Primary Completion (ACTUAL)

February 24, 2021

Study Completion (ACTUAL)

April 6, 2021

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (ACTUAL)

December 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tayfun1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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