High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Success rate of bronchoscopy
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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)
研究组 & 干预措施
conventional oxygen therapy
conventional nasal prong with FiO2 ~0.4
HFNOT
high flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min
干预措施: HFNOT (Device)
sham-HFNOT
same device with FiO2 ~0.4, NO high flow
干预措施: HFNOT (Device)
结局指标
主要结局
Success rate of bronchoscopy
时间窗: 1 day
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.
Total duration of hypoxia
时间窗: 1 day
total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.
次要结局
- frequency of hypoxia(1 day)
- switch to oxygen therapy method(1 day)
- change of respiratory symptoms(1 day)
研究者
Young-Jae Cho
Seoul National University Bundang Hospital
Seoul National University Bundang Hospital