[JAMA最新论文]：心跳骤停期间经鼻蒸汽冷却对院外心跳骤停患者神经系统功能预后的影响—PRINCE...

Effect of Trans-Nasal Evaporative Intra-arrest Cooling on Functional Neurologic Outcome in Out-of-Hospital Cardiac Arrest: The PRINCESS Randomized Clinical Trial

Per Nordberg, Fabio Silvio Taccone, Anatolij Truhlar, et al

JAMA. 2019;321(17):1677-1685. doi:10.1001/jama.2019.4149

Importance 背景

Therapeutic hypothermia may increase survival with good neurologic outcome after cardiac arrest. Trans-nasal evaporative cooling is a method used to induce cooling, primarily of the brain, during cardiopulmonary resuscitation (ie, intra-arrest).

心跳骤停后实施治疗性低温能够增加存活且神经系统预后良好的患者比例。经鼻蒸汽冷却是在心肺复苏期间主要用于脑部冷却的方法。

Objective 目的

To determine whether prehospital trans-nasal evaporative intra-arrest cooling improves survival with good neurologic outcome compared with cooling initiated after hospital arrival.

确定与抵达医院后开始降温治疗相比，院前心跳骤停期间经鼻蒸汽冷却能否改善存活且神经系统预后良好的患者比例。

Design, Setting, and Participants 试验设计，场景及研究人群

The PRINCESS trial was an investigator-initiated, randomized, clinical, international multicenter study with blinded assessment of the outcome, performed by emergency medical services in 7 European countries from July 2010 to January 2018, with final follow-up on April 29, 2018. In total, 677 patients with bystander-witnessed out-of-hospital cardiac arrest were enrolled.

PRINCESS试验是一项研究者发起的随机临床国际多中心研究。由7个欧洲国家的急诊医疗服务进行，研究期限为2010年7月至2018年1月，最后随访日期为2018年4月29日，预后评估设盲。共入选677名旁观者目击的院外心跳骤停患者。

Interventions 干预措施

Patients were randomly assigned to receive trans-nasal evaporative intra-arrest cooling (n = 343) or standard care (n = 334). Patients admitted to the hospital in both groups received systemic therapeutic hypothermia at 32°C to 34°C for 24 hours.

患者接受随机分组，分别接受心跳骤停期间经鼻蒸汽冷却(n = 343)或标准治疗(n = 334)。两组患者入院后均接受全身治疗性低温治疗24小时，维持核心体温32°C至34°C。

Main Outcomes and Measures 主要预后指标

The primary outcome was survival with good neurologic outcome, defined as Cerebral Performance Category (CPC) 1-2, at 90 days. Secondary outcomes were survival at 90 days and time to reach core body temperature less than 34°C.

主要预后指标为存活且神经系统预后良好，定义为90天时脑功能分类(CPC) 1-2分。次要预后指标为90天生存率，及核心体温达到34°C以下所需时间。

Results 结果

Among the 677 randomized patients (median age, 65 years; 172 [25%] women), 671 completed the trial. Median time to core temperature less than 34°C was 105 minutes in the intervention group vs 182 minutes in the control group (P < .001). The number of patients with CPC 1-2 at 90 days was 56 of 337 (16.6%) in the intervention cooling group vs 45 of 334 (13.5%) in the control group (difference, 3.1% [95% CI, −2.3% to 8.5%]; relative risk [RR], 1.23 [95% CI, 0.86-1.72]; P = .25). In the intervention group, 60 of 337 patients (17.8%) were alive at 90 days vs 52 of 334 (15.6%) in the control group (difference, 2.2% [95% CI, −3.4% to 7.9%]; RR, 1.14 [95% CI, 0.81-1.57]; P = .44). Minor nosebleed was the most common device-related adverse event, reported in 45 of 337 patients (13%) in the intervention group. The adverse event rate within 7 days was similar between groups.

总共 677 名接受随机分组的患者（中位年龄，65 岁；172 名[25%] 女性），671名患者完成临床试验。干预组核心体温达到34°C以下所需时间中位数为 105 分钟，对照组为182 分钟(P < .001)。90天时，干预组337名患者中56名 (16.6%)及对照组334名患者中45名 (13.5%)的CPC评分1-2分（差异，3.1% [95% CI, −2.3% to 8.5%]; 相对危险度 [RR], 1.23 [95% CI, 0.86-1.72]; P = .25）。90天时，干预组337名患者中60名 (17.8%)及对照组334名患者中52名 (15.6%) 存活（差异，2.2% [95% CI, −3.4% to 7.9%]; RR, 1.14 [95% CI, 0.81-1.57]; P = .44）。轻度鼻出血是最常见的设备相关不良事件，干预组337名患者中45名(13%)出现轻度鼻出血。两组患者7天内不良事件发生率相似。

Conclusions and Relevance 结论与意义

Among patients with out-of-hospital cardiac arrest, trans-nasal evaporative intra-arrest cooling compared with usual care did not result in a statistically significant improvement in survival with good neurologic outcome at 90 days.

对于院外心跳骤停患者，与常规治疗相比，心跳骤停期间经鼻蒸汽冷却并不能显著改善90天时存活且神经系统预后良好患者比例。

Trial Registration  ClinicalTrials.gov Identifier: NCT01400373

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