High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial

NCT ID: NCT03892408

Last Updated: 2024-06-13

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-21

Study Completion Date

2022-08-19

Brief Summary

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The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.

Detailed Description

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Conditions

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Foreign Bodies Tumor Stenosis Trachea Bronchus Tumour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective Randomized, open label Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

triple (Participant, Care Provider, investigator)

Study Groups

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Optiflow

100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand)

Group Type EXPERIMENTAL

Optiflow ™

Intervention Type DEVICE

supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.

Standard

standard anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Optiflow ™

supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
* 2\. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion Criteria

* 1\. Patients with dementia or cognitive impairment
* 2\. pregnant women
* 3\. Patients undergoing extracorporeal membrane oxygenation (ECMO)
* 4\. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
* 5\. Patients with current maxillofacial trauma or basal skull fracture
* 6\. Patients who had previously undergone rigid bronchoscopy / surgery
* 7\. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1-2019-0005

Identifier Type: -

Identifier Source: org_study_id

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