Hospital and long-term outcomes for subglottic suction and polyurethane cuff versus standard endotracheal tubes in emergency intubation (PreVent 2): a randomised controlled phase 2 trial.

However, their long-term safety and efficacy after emergency intubation are uncertain.

然而，它们在紧急插管后的长期安全性和有效性尚不确定。

Methods

In this randomised controlled phase 2 trial conducted at two single centres (Oregon Health and Science University [OHSU, Portland, OR, USA] and Yale New Haven Hospital [YNHH, New Haven, CT, USA]), all patients aged 18 years or older requiring endotracheal intubation either in the emergency department or elsewhere in hospital for acute respiratory distress or failure were randomly assigned to receive a polyurethane-cuffed endotracheal tube with subglottic suction (PU-EVAC) or a polyvinylchloride-cuffed endotracheal tube (PVC).

在这项在两个单一中心进行的随机对照二期试验中（俄勒冈健康与科学大学[OHSU, 俄勒冈州波特兰]和耶鲁纽黑文医院[YNHH, 康涅狄格州纽黑文]），所有18岁或以上的患者，无论是在急诊科还是在医院其他地方因急性呼吸窘迫或衰竭需要气管插管，都被随机分配接受聚氨酯气囊的气管插管并带有声门下吸引（PU-EVAC）或聚氯乙烯气囊的气管插管（PVC）。

Individuals who were electively intubated in the operating room and protected populations (children [aged younger than 18 years], pregnant women, and prisoners) were ineligible to participate.

那些在手术室被选择性插管的个体和受保护的人群（儿童[年龄小于18岁]、孕妇和囚犯）没有资格参与。

Patients were randomised 1:1 into the two treatment arms using a fair coin randomisation scheme.

患者按照1:1的比例通过公正的硬币随机化方案分配到两个治疗组。

Patients assigned to the PVC group were treated according to usual care, and patients assigned to the PU-EVAC group received continuous subglottic suctioning until removal of the endotracheal tube.

被分配到PVC组的患者接受常规护理治疗，而被分配到PU-EVAC组的患者则接受持续的声门下吸引，直到气管插管被移除。

The coprimary endpoints at 6 months were laryngeal injury, quality of life (Short Form-36 [SF-36] physical component summary [PCS] and mental component summary [MCS] scores), and cognitive function.

6个月时的共同主要终点是喉部损伤、生活质量（Short Form-36 [SF-36]身体成分总结[PCS]和精神成分总结[MCS]得分）以及认知功能。

Secondary endpoints were infection-related ventilator-associated complications (IVAC) and possible ventilator-associated pneumonia (VAP).

次要终点是与感染相关的呼吸机相关并发症（IVAC）和可能的呼吸机相关肺炎（VAP）。

This trial is registered at ClinicalTrials.gov (NCT03705286) and is now completed.

该试验已在ClinicalTrials.gov注册（NCT03705286），目前试验已完成。

Results

Between May 6, 2019, and July 31, 2019 (Oregon Health and Science University), and Sept 29, 2020, to Feb 11, 2022 (Yale New Haven Hospital), 1074 adult patients were enrolled and 1068 were randomly assigned to either the PVC (n=533) or the PU-EVAC (n=535) endotracheal tube group.

在2019年5月6日至2019年7月31日（俄勒冈健康与科学大学）以及2020年9月29日至2022年2月11日（耶鲁纽黑文医院）期间，共有1074名成年患者被纳入研究，并有1068名患者被随机分配至PVC组（n=533）或PU-EVAC组（n=535）的气管导管。

Participants had a mean age at intubation of 62·9 years (SD 15·7), were mostly male (671 [63%] of 1068), and mostly White (718 [67%]).

参与者在插管时的平均年龄为62.9岁（标准差15.7），大多数为男性（1068名参与者中有671名，占63%），大多数为白人（1068名参与者中有718名，占67%）。

IVAC occurred in 43 (8%) of 535 patients in the PU-EVAC group and in 33 (6%) of 533 patients in the PVC group (risk difference 0·02 [95% CI -0·01 to 0·05]); possible VAP occurred in 30 (6%) patients in the PU-EVAC group and 24 (5%) patients in the PVC group (0·01 [-0·02 to 0·04]).

在PU-EVAC组的535名患者中，有43名（8%）发生了IVAC，在PVC组的533名患者中，有33名（6%）发生了IVAC（风险差异0.02 [95% 置信区间-0.01至0.05]）；可能的VAP在PU-EVAC组的30名（6%）患者和PVC组的24名（5%）患者中发生（0.01 [-0.02至0.04]）。

At 6-month follow-up, 558 patients had died (274 [51%] in the PU-EVAC group and 284 [53%] in the PVC group). 157 completed the 6-month follow-up visit.

在6个月的随访中，共有558名患者死亡（PU-EVAC组274人[51%]，PVC组284人[53%]）。157名患者完成了6个月的随访访问。

Laryngeal injury was reported in 71 (83%) of 86 patients in the PU-EVAC group and in 49 (70%) of 70 patients in the PVC group (0·11 [-0·03 to 0·20]; p=0·098).

在PU-EVAC组的86名患者中，有71人（83%）报告了喉部损伤，在PVC组的70名患者中，有49人（70%）报告了喉部损伤（0·11 [-0·03到0·20]；p=0·098）。

Mean PCS was 39·97 (SD 10·97) in the PU-EVAC group and 40·49 (11·92) in the PVC group (mean difference -0·52 [95% CI -4·21 to 3·17]; p=0·78) and mean MCS was 45·91 (13·10) in the PU-EVAC group and 48·89 (12·22) in the PVC group (-2·98 [-7·03 to 1·07]; p=0·15).

PU-EVAC组的平均躯体成分评分（PCS）为39.97（标准差10.97），PVC组为40.49（11.92）（平均差异-0.52 [95% 置信区间-4.21至3.17]；p=0.78），PU-EVAC组的平均心理成分评分（MCS）为45.91（13.10），PVC组为48.89（12.22）（平均差异-2.98 [-7.03至1.07]；p=0.15）。

Cognitive impairment was present in 70 (85%) of 82 in the PU-EVAC group and 54 (81%) of 67 patients in the PVC group (risk difference 0·05 [-0·07 to 0·17]; p=0·44).

PU-EVAC组中有70名（85%）的82名患者存在认知障碍，而PVC组中有54名（81%）的67名患者存在认知障碍（风险差异0.05 [-0.07至0.17]；p=0.44）。

interpretation

The PU-EVAC did not reduce the incidenceof IVAC or possible VAP compared with a standard PVC endotracheal tube with no subglottic drainage.

PU-EVAC并未降低IVAC或可能的VAP发生率，与无次声门下引流的标准PVC气管导管相比。

At 6-month follow-up, neither quality of life, cognitive function, nor laryngeal injury differed between groups.

在6个月的随访中，两组在生活质量、认知功能或喉部损伤方面均无差异。

However, the small number of survivors who provided information on their physical and mental status limits the conclusions that can be drawn regarding long-term outcome differences.

然而，提供有关其身心状态信息的幸存者数量有限，限制了关于长期结果差异的结论的推导。

funding

National Institutes of Health and National Heart, Lung, and Blood Institute.

国家卫生研究院和国家心肺血液研究所。