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

Yonsei University1 site in 1 country56 target enrollmentApril 21, 2019

ConditionsForeign Bodies Tumor Stenosis Trachea Bronchus Tumour

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Foreign Bodies
Sponsor: Yonsei University
Enrollment: 56
Locations: 1
Primary Endpoint: the lowest oxygen saturation
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 21, 2019

End Date

August 19, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

the lowest oxygen saturation

Time Frame: apnea period during the rigidbroscopic procedure/surgery

the lowest value of oxygen saturation measured percutaneously at extremity.

Secondary Outcomes

Hypoxia occurs the first time(intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea))
End-tidal carbon dioxide partial pressure(Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea))
Arterial oxygen / carbon dioxide partial pressure(shortly after end of apnea (within 30 seconds))
hypoxemia related surgical interruptions(4) hypoxemia related surgical interruptions during apneic period)