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原发性膝关节或髋关节置换术中自热毯与强制空气加热的比较:一项随机对照非劣效性研究。

Self-Warming Blanket Versus Forced-Air Warming in Primary Knee or Hip Replacement: A Randomized Controlled Non-Inferiority Study.

作者信息

Verra Wiebe Christiaan, Beekhuizen Stefan Robin, van Kampen Paulien Maria, de Jager Marie Claire, Deijkers Rudolf Leonardus Maria, Tordoir Rutger Laurens

机构信息

Department of Orthopaedic Surgery, Medisch Spectrum Twente, Enschede, the Netherlands.

Department of Orthopaedic Surgery, HagaZiekenhuis, the Hague, the Netherlands.

出版信息

Asian J Anesthesiol. 2018 Dec;56(4):128-135. doi: 10.6859/aja.201812_56(4).0002.

DOI:10.6859/aja.201812_56(4).0002
PMID:30922017
Abstract

OBJECTIVE

After primary total knee/hip replacement (TKR or THR respectively) a prosthetic joint infection (PJI) could develop. Hypothermia could raise the risk of infection. Heating by forced-air can disrupt laminar airfl ow in the operation room (OR), potentially raising the risk of infection. We aimed to study non-inferiority of an active self-heating blanket (SHB) compared to a forced-air blanket (FAB) in preventing hypothermia.

METHODS

A randomized controlled non-inferiority trial (N = 86 patients) was performed comparing a SHB versus a FAB in elective primary TKR/THR patients. Primary outcome was lowest measured temperature during surgery. Secondary outcomes were patients' core temperature before, during, and after surgery, thermal comfort visual analogue score (VAS) and complications during hospitalization.

RESULTS

Lowest measured temperature was 35.9°C (± 0.6) in SHB and 36.1°C (± 0.5) in FAB group (p = 0.05). No signifi cant correlation was found with duration of surgery or temperature of the OR. No signifi cant difference in core temperature was found before surgery (SHB = 36.8°C [± 0.4], FAB = 36.8°C [± 0.5], p = 0.49), after induction of anaesthesia (SHB = 36.6°C [± 0.5], FAB = 36.7°C [± 0.5], p = 0.22) nor as a mean during surgery (SHB = 35.8°C [± 1.6], FAB = 36.0°C [± 1.3], p = 0.68). SHB patients were "colder" at the recovery bay, 35.8°C (± 0.6) compared to FAB patients, 36.1°C (± 0.5) (p = 0.04). Mean VAS thermal comfort was 53.3 (± 15.7) in SHB and 52.9 (± 12.3) in FAB patients. No difference in complication rate was found.

CONCLUSIONS

In this study neither kind of the warming blanket prevented perioperative hypothermia. Although a difference of 0.2°C was found between both groups at the end of TKR/THR surgery, this is most probably not clinically relevant. Complication rate in both groups was the same.

摘要

目的

在初次全膝关节/髋关节置换术(分别为TKR或THR)后,可能会发生人工关节感染(PJI)。体温过低可能会增加感染风险。强制空气加热可能会扰乱手术室(OR)中的层流,从而可能增加感染风险。我们旨在研究活性自热毯(SHB)与强制空气毯(FAB)在预防体温过低方面的非劣效性。

方法

进行了一项随机对照非劣效性试验(N = 86例患者),比较择期初次TKR/THR患者使用SHB与FAB的情况。主要结局是手术期间测量的最低体温。次要结局是患者手术前、手术期间和手术后的核心体温、热舒适度视觉模拟评分(VAS)以及住院期间的并发症。

结果

SHB组测量的最低体温为35.9°C(±0.6),FAB组为36.1°C(±0.5)(p = 0.05)。未发现与手术时间或手术室温度有显著相关性。手术前核心体温无显著差异(SHB = 36.8°C [±0.4],FAB = 36.8°C [±0.5],p = 0.49),麻醉诱导后(SHB = 36.6°C [±0.5],FAB = 36.7°C [±0.5],p = 0.22)以及手术期间的平均体温(SHB = 35.8°C [±1.6],FAB = 36.0°C [±1.3],p = 0.68)也无显著差异。在恢复室,SHB组患者的体温“更低”,为35.8°C(±0.6),而FAB组患者为36.1°C(±0.5)(p = 0.04)。SHB组患者热舒适度的平均VAS评分为53.3(±15.7),FAB组患者为52.9(±12.3)。并发症发生率无差异。

结论

在本研究中,两种保暖毯均未预防围手术期体温过低。尽管在TKR/THR手术结束时两组之间发现了0.2°C的差异,但这很可能与临床无关。两组的并发症发生率相同。

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