一项关于重症患者气管切开时机的随机临床试验：排除纳入单中心研究的因素。
A randomized clinical trial for the timing of tracheotomy in critically ill patients: factors precluding inclusion in a single center study.
作者信息
Diaz-Prieto Antonio, Mateu Antoni, Gorriz Maite, Ortiga Berta, Truchero Consol, Sampietro Neus, Ferrer María Jesus, Mañez Rafael
机构信息
Servei de Medicina Intensiva, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain.
Departament de Gerencia, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain.
出版信息
Crit Care. 2014 Oct 29;18(5):585. doi: 10.1186/s13054-014-0585-y.
INTRODUCTION
We investigated the potential benefits of early tracheotomy performed before day eight of mechanical ventilation (MV) compared with late tracheotomy (from day 14 if it still indicated) in reducing mortality, days of MV, days of sedation and ICU length of stay (LOS).
METHODS
Randomized controlled trial (RCT) including all-consecutive ICU admitted patients requiring seven or more days of MV. Between days five to seven of MV, before randomization, the attending physician (AP) was consulted about the expected duration of MV and acceptance of tracheotomy according to randomization. Only accepted patients received tracheotomy as result of randomization. An intention to treat analysis was performed including patients accepted for the AP and those rejected without exclusion criteria.
RESULTS
A total of 489 patients were included in the RCT. Of 245 patients randomized to the early group, the procedure was performed for 167 patients (68.2%) whereas in the 244 patients randomized to the late group was performed for 135 patients (55.3%) (P <0.004). Mortality at day 90 was similar in both groups (25.7% versus 29.9%), but duration of sedation was shorter in the early tracheotomy group median 11 days (range 2 to 92) days compared to 14 days (range 0 to 79) in the late group (P <0.02). The AP accepted the protocol of randomization in 205 cases (42%), 101 were included in early group and 104 in the late group. In these subgroup of patients (per-protocol analysis) no differences existed in mortality at day 90 between the two groups, but the early group had more ventilator-free days, less duration of sedation and less LOS, than the late group.
CONCLUSIONS
This study shows that early tracheotomy reduces the days of sedation in patients undergoing MV, but was underpowered to prove any other benefit. In those patients selected by their attending physicians as potential candidates for a tracheotomy, an early procedure can lessen the days of MV, the days of sedation and LOS. However, the imprecision of physicians to select patients who will require prolonged MV challenges the potential benefits of early tracheotomy.
TRIAL REGISTRATION
Controlled-Trials.com ISRCTN22208087 . Registered 27 March 2014.
引言
我们研究了在机械通气（MV）第8天之前进行早期气管切开术与晚期气管切开术（从第14天起，若仍有指征）相比，在降低死亡率、MV天数、镇静天数和重症监护病房住院时间（LOS）方面的潜在益处。
方法
随机对照试验（RCT），纳入所有连续入住重症监护病房且需要进行7天或更长时间MV的患者。在MV的第5至7天，随机分组前，就MV的预期持续时间和根据随机分组接受气管切开术的情况咨询主治医生（AP）。只有被接受的患者因随机分组而接受气管切开术。进行意向性分析，纳入被AP接受的患者以及无排除标准而被拒绝的患者。
结果
RCT共纳入489例患者。在随机分为早期组的245例患者中，167例（68.2%）进行了该手术，而在随机分为晚期组的244例患者中，135例（55.3%）进行了该手术（P<0.004）。两组在第90天的死亡率相似（25.7%对29.9%），但早期气管切开术组的镇静持续时间较短，中位数为11天（范围2至92天），而晚期组为14天（范围0至79天）（P<0.02）。AP在205例（42%）病例中接受了随机分组方案，101例纳入早期组，104例纳入晚期组。在这些患者亚组（符合方案分析）中，两组在第90天的死亡率无差异，但早期组的无呼吸机天数更多、镇静持续时间更短且LOS更短。
结论
本研究表明，早期气管切开术可减少接受MV患者的镇静天数，但在证明其他益处方面力度不足。在那些被主治医生选为气管切开术潜在候选人的患者中，早期手术可减少MV天数、镇静天数和LOS。然而，医生选择需要长期MV患者的不精确性对早期气管切开术的潜在益处提出了挑战。
试验注册
Controlled-Trials.com ISRCTN22208087。2014年3月27日注册。
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