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

NCT ID: NCT04686656

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-24

Study Completion Date

2021-04-06

Brief Summary

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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

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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.

Conditions

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Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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nasal oxygen supplementation group

supplemental oxygen will be administered with nasal cannula

Group Type ACTIVE_COMPARATOR

nasal oxygen

Intervention Type OTHER

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

buccal oxygen supplementation group

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

Group Type ACTIVE_COMPARATOR

buccal oxygen

Intervention Type OTHER

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

Interventions

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nasal oxygen

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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tayfun sugur, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Locations

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Antalya Training and Researching Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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tayfun1

Identifier Type: -

Identifier Source: org_study_id

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