Comparison of Asymmetric High-flow Nasal Cannula (HFNC) and Standard HFNC in Post Extubation High-risk Group: A Prospective, Single-center, Open-labeled, Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Respiratory Rate Oxygenation (ROX) Index
研究概览
简要总结
Background The exacerbation of respiratory failure that occurs after endotracheal intubation often occurs in patients who have received mechanical ventilation therapy, and when it occurs, it emerges as an important issue to consider reintubation of endotracheal intubation. High-flow nasal cannula (HFNC) through nasal cannula is known to produce positive airway pressure and deliver a certain amount of oxygen, and recently reported clinical studies have demonstrated the effect of lowering the risk of reintubation after endotracheal intubation, which is recommended for use in recent clinical practice guidelines. However, in patients at high risk of intubation failure, the combination of high-flow oxygen therapy and non-invasive positive-pressure ventilation therapy rather than the application of high-flow oxygen therapy alone through nasal cannula is helpful in reducing the rate of reintubation of endotracheal intubation. However, an alternative to non-invasive positive-pressure ventilation therapy is needed as there is a possibility of complications such as aspiration pneumonia, maladaptation of the application device (mask), and discomfort, making it difficult to apply it in the field.
Recently, it has been reported that high flow oxygen therapy through an asymmetric nasal cannula forms sufficient positive pressure in terms of respiratory dynamics, which makes the patient feel comfortable and reduces work of breath. However, no clinical studies have yet compared physiological effects using this method in patients at high risk of extubation failure.
Goal The investigators would like to compare the physiological effects of high flow oxygen therapy through 'asymmetric nasal cannula' with high flow oxygen therapy through 'standard nasal cannula' in patients identified as high-risk groups for valvular failure.
Hypothesis 'Asymmetric nasal cannula' reduces work of breath compared to 'standard nasal cannula' in high-risk patients with valvular failure.
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
- Single (Outcomes Assessor)
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
- •19 years of age or older
- •Patients who applied mechanical ventilation treatment for more than 24 hours before the excision
- •Patients who underwent endotracheal intubation rather than tracheal incision
- •Planned extubation after successful spontaneous breathing trial (SBT)
- •Reintubation High Risk Patients: If any of the following conditions are met
- •Acute Physiology and Chronic Health Evaluation(APACHE) II on the day of extubation > 12
- •Body mass index (BMI) > 30 kg/m2
- •Inability to deal with respiratory secretions
- •improper cough reflex
- •If at least three aspirations are required in the 8 hours prior to the discharge
- •Difficult or long delay in mechanical ventilation
- •The first attempt to leave the mechanical ventilation failed
- •Charlson Commercial Index (CCI) at least 2 categories of comorbidities
- •Heart failure is the main indication of mechanical ventilation application
- •Moderate to severe chronic obstructive pulmonary disease
- •If there is a problem with airway openness (high risk of developing laryngeal edema)
- •Oral endotracheal intubation maintenance period of at least 3 days
- •Difficult to intubate endotracheally (difficult airway)
- •Long-term mechanical ventilation application: When applied for more than 7 days
排除标准
- •a patient with a tracheostomy tube
- •Contraindicated application of nasal interfaces
- •a nasal disorder
- •Continuous positive pressure (CPAP) application contraindications
- •pneumothorax, blistering lung disease, head trauma, cranial facial surgery, airway foreign matter, unstable hemodynamics, etc
- •EIT application contraindications
- •Patients using implantable electronic medical devices (such as implantable defibrillators, pacemakers or spinal cord stimulators)
- •a patient with hyperhidrosis
- •a patient whose physical movements are not controlled
- •a pregnant woman
- •BMI 50 or higher
结局指标
主要结局
Respiratory Rate Oxygenation (ROX) Index
时间窗: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
Changes in Respiratory Rate Oxygenation (ROX) Index after extubation 4.88 ≤ ROX index ; Low Risk 3.85 ≤ ROX index \< 4.88 ; Re-evaluate after 1-2 hours 3.85 \> ROX index ; considerate about intubation
次要结局
- The Lowest value of SpO2 within 24 hours after extubation(within 24 hours after extubation)
- changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)(1 hour, 2 hours, 6 hours, 12 hours, 24 hours)
- mean arterial pressure(1 hour, 2 hours, 6 hours, 12 hours, 24 hours)
- ICU Mortality(From date of extubation until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 1 year)
- 28 Day Mortality(From date of extubation until the date of 28 Day or date of death from any cause, whichever came first, assessed up to 1 months)
- systolic blood pressure(1 hour, 2 hours, 6 hours, 12 hours, 24 hours)
- Hospital Mortality(From date of extubation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 year)
- PaO2/FiO2(30 minutes, 6 hours, 24 hours)
- SpO2/FiO2(1 hour, 2 hours, 6 hours, 12 hours, 24 hours)
- Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)(1 hour, 2 hours, 6 hours, 12 hours, 24 hours)
- Respiratory rate(1 hour, 2 hours, 6 hours, 12 hours, 24 hours)
- work of breath (Modified Borg Scale, MBS)(1 hour, 2 hours, 6 hours, 12 hours, 24 hours)
- heart rate(1 hour, 2 hours, 6 hours, 12 hours, 24 hours)
- Rate of reintubation within 7 days(within 7 days after extubation)
- Length of ICU stay(From date of ICU admission until the date of ICU discharge, assessed up to 2 years)
- 90 Day Mortality(From date of extubation until the date of 90 Day or date of death from any cause, whichever came first, assessed up to 3 months)
- Length of hospital stay(From date of hospital admission until the date of hospital discharge, assessed up to 2 years)
研究者
Chi Ryang Chung
Professor
Samsung Medical Center