McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX; Memorial Hermann Hospital-Texas Medical Center, Houston, TX.
University of Tennessee, Chattanooga, TN; Erlanger Health System, Chattanooga, TN.
Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.
We compare high-velocity nasal insufflation, a form of high-flow nasal cannula, with noninvasive positive-pressure ventilation in the treatment of undifferentiated respiratory failure with respect to therapy failure, as indicated by requirement for endotracheal intubation or cross over to the alternative therapy.
This was a multicenter, randomized trial of adults presenting to the emergency department (ED) with respiratory failure requiring noninvasive positive-pressure ventilation. Patients were randomly assigned to high-velocity nasal insufflation (initial flow 35 L/min; temperature 35°C (95°F) to 37°C (98.6°F); FiO 1.0) or noninvasive positive-pressure ventilation using an oronasal mask (inspiratory positive airway pressure 10 cm HO; expiratory positive airway pressure 5 cm HO). The primary outcome was therapy failure at 72 hours after enrollment. A subjective outcome of crossover was allowed as a risk mitigation to support deferment of informed consent. Noninferiority margins were set at 15 and 20 percentage points, respectively.
A total of 204 patients were enrolled and included in the analysis, randomized to high-velocity nasal insufflation (104) and noninvasive positive-pressure ventilation (100). The intubation rate (high-velocity nasal insufflation=7%; noninvasive positive-pressure ventilation=13%; risk difference=-6%; 95% confidence interval -14% to 2%) and any failure of the assigned arm (high-velocity nasal insufflation=26%; noninvasive positive-pressure ventilation=17%; risk difference 9%; confidence interval -2% to 20%) at 72 hours met noninferiority. The effect on PCO over time was similar in the entire study population and in patients with baseline hypercapnia. Vital signs and blood gas analyses improved similarly over time. The primary limitation was the technical inability to blind the clinical team.
High-velocity nasal insufflation is noninferior to noninvasive positive-pressure ventilation for the treatment of undifferentiated respiratory failure in adult patients presenting to the ED.
我们比较了高流速鼻内吹入（一种高流量鼻导管）与无创正压通气治疗未分化性呼吸衰竭的效果，以气管插管或交叉至替代治疗所需的治疗失败为指标。
这是一项多中心、随机临床试验，纳入因呼吸衰竭而需接受无创正压通气治疗的急诊科成年患者。患者被随机分配至高流速鼻内吹入（初始流量 35 L/min；温度 35°C（95°F）至 37°C（98.6°F）；FiO1.0）或口鼻面罩无创正压通气（吸气气道正压 10 cm H2O；呼气气道正压 5 cm H2O）。主要结局为入组后 72 小时的治疗失败。允许交叉作为风险缓解的主观结局，以支持推迟知情同意。非劣效性边界分别设定为 15%和 20%。
共纳入 204 例患者并进行了分析，随机分配至高流速鼻内吹入（104 例）和无创正压通气（100 例）。气管插管率（高流速鼻内吹入=7%；无创正压通气=13%；风险差异=-6%；95%置信区间 -14%至 2%）和指定治疗臂的任何失败（高流速鼻内吹入=26%；无创正压通气=17%；风险差异 9%；置信区间 -2%至 20%）在 72 小时均符合非劣效性。整个研究人群和基线高碳酸血症患者的 PCO 随时间的变化趋势相似。生命体征和血气分析随时间的变化相似。主要限制是临床团队无法进行技术盲法。
高流速鼻内吹入在治疗急诊科成年未分化性呼吸衰竭患者方面不劣于无创正压通气。
