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

Study Overview
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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.

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

Conditions
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Foreign Bodies, Tumor, Stenosis Trachea, Bronchus Tumour

Intervention / Treatment
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* Device: Optiflow ™


Participation Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective Randomized, open label Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optiflow<br>100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) | Device: Optiflow ™<br>* 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.<br>|
| No Intervention: Standard<br>standard anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the lowest oxygen saturation | the lowest value of oxygen saturation measured percutaneously at extremity. | apnea period during the rigidbroscopic procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 before start of apnea (within 30 seconds) | 
| Arterial oxygen / carbon dioxide partial pressure |  | shortly after end of apnea (within 30 seconds) |