High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.

Detailed Description
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Hypoxemia is frequently seen during diagnostic bronchoscopy. Nasal prong or other existing oxygen supply methods are often difficult to maintain adequate oxygenation during bronchoscopy. In particular, bronchoscopy to patients already showing hypoxemia can be dangerous even though applying conventional oxygen therapy. Thus, we want to elucidate the usefulness of nasal high flow oxygen therapy to hypoxemic patients undergoing diagnostic bronchoscopy.

Official Title
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High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study

Conditions
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Hypoxia

Intervention / Treatment
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* Device: HFNOT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 or 2 PaO2 < 60 mmHg on ABGA or SpO2 < 90 % in room air AND SpO2 ≥ 95% or PaO2 ≥ 75mmHg in low flow oxygen therapy Planning to diagnostic bronchoscopic procedure (e.g. bronchial washing, BAL, bronchoscopic biopsy, EBUS-TBNA etc.) Exclusion Criteria: patients who did not agree to provide information patients requiring for emergent intubation patients can not wear or be already applied high flow nasal oxygen therapy patients with unstable vital sign(e.g. severe hypotension, uncontrolled arrhythmia, etc.) patients with multiple organ failures patients with plan to therapeutic bronchoscopic procedure(e.g. intervention)

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional oxygen therapy<br>conventional nasal prong with FiO2  0.4 | |
| Experimental: HFNOT<br>high flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min | Device: HFNOT<br>* high flow nasal oxygen therapy<br>* Other names: high flow nasal oxygen therapy(OPTIFLOW);|
| Sham Comparator: sham-HFNOT<br>same device with FiO2  0.4, NO high flow | Device: HFNOT<br>* high flow nasal oxygen therapy<br>* Other names: high flow nasal oxygen therapy(OPTIFLOW);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of bronchoscopy | Success is defined as completion of planned diagnostic procedure with the oxygen saturation or partial pressure of oxygen in arterial blood was similar to the level of before the procedure. Failure is defined as incompletion of planned diagnostic procedure due to sustained hypoxemia or else. Furthermore failure is defined as hypoxemia(SaO2 <88%) was developed more than 2 times even though planned procedure was completed. | 1 day | 
| Total duration of hypoxia | total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of hypoxia | frequency of hypoxia(oxygen saturation ≤88%) during procedure or after procedure. | 1 day | 
| switch to oxygen therapy method | Increase oxygen apply or change of oxygen therapy method to high flow system. | 1 day | 
| change of respiratory symptoms | scoring of dyspnea symptoms, patients comfort. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic bronchoscopy, high flow nasal oxygen therapy