High Flow Nasal Cannula (HFNC) Versus Standard Low Flow Nasal Cannula (LFNC) in Patients with Atrial Fibrillation Undergoing Radiofrequency Catheter Ablation (RFCA) Under Deep Desaturation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Hypoxemia event
研究概览
简要总结
Oxygen supplementation through high flow nasal cannula (HFNC) may reduce the incidence of desaturation and hypoxemia during deep sedation at radiofrequency catheter ablation (RFCA procedures).This study is designed to test the hypothesis that the incidence of hypoxemia and desaturation in patients with atrial fibrillation undergoing RFCA under deep sedation, is less when using HFNC as compared to use of standard low flow nasal cannula (LFNC).
详细描述
Desaturation may occur in patients under deep sedation which results in an elevated risk for perioperative adverse events including hypoxemia (1-3). The incidence of hypoxemia was 168 per 1000 in a general procedural sedation and analgesia population (4). The clinical significance of transient episodes of hypoxemia remains debatable. However, many peri-operative incidents are often short-term and limited in nature, but a number of them are a predictor to a serious complication with a permanent injury (5).This study investigates if high flow nasal cannula (HFNC) as compared to low flow nasal cannula (LFNC) will result in a lower incidence of intra-procedural oxygen desaturation and hypoxemia in patients with atrial fibrillation undergoing deep sedation for radiofrequency catheter ablation (RFCA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing an elective RFCA for atrial fibrillation in the Maastricht UMC Cardiac Catheter Labs under deep sedation administered by a clinician anesthesiology
排除标准
- •Age under 18 years
- •Body Mass Index (BMI) > 32 kg/m²
- •Diagnosed Sleep Apnoea Syndrome (SAS)
- •Chronic Pulmonary Obstructive Disease (COPD) gold IV and COPD gold III with frequent or recent exacerbation
- •Diagnosed pulmonary or cardiac condition requiring chronic oxygen therapy
- •Complete nasal obstruction
- •Active nose bleeding
- •Untreated pneumothorax (pre- existing)
- •Recent upper airway surgery
- •Recent base of skull fracture
- •Expected difficult airway
结局指标
主要结局
Hypoxemia event
时间窗: The outcome variable will be measured during the patient's sedation (0-4 hours).
The primary outcome measure will be the lowest measured blood oxygen level during the patient's sedation.
次要结局
- Cross over from oxygen therapy(The outcome variable will be measured during the patient's sedation (0-4 hours).)
- To measure the incidence of hypoxemia and desaturation (SpO2 under 90% for > 60 seconds).(The outcome variable will be measured during the patient's sedation (0-4 hours).)
- Duration of hypoxemia event(The outcome variable will be measured during the patient's sedation (0-4 hours).)