Hull University Teaching Hospitals NHS Trust, Hull, UK.
Hull and York Medical School, York, UK.
J Clin Nurs. 2020 Apr;29(7-8):1085-1093. doi: 10.1111/jocn.15159. Epub 2020 Jan 20.
To determine the clinical effectiveness and safety of the Orve + wrap® thermal blanket.
Inadvertent perioperative hypothermia is a common problem in postanaesthetic care units and can have significant effects on patients' postoperative morbidity. Despite its commercial availability, there is no clinical evidence on the effectiveness of Orve + wrap®.
A single centre prospective, open-label, noninferiority randomised controlled trial.
Postoperative hypothermic (35.0-35.9°C) patients who had undergone elective surgery were randomised to receive either Orve + wrap® or Forced Air Warming during their PACU stay. Patient temperatures were recorded every 10 min using zero-heat-flux thermometry. This study is reported using CONSORT Extension checklist for noninferiority and equivalence trials.
Between December 2016-October 2018, 129 patients were randomised to receive either Orve + wrap® blanket (n = 65, 50.3%) or Forced Air Warming (n = 64, 49.7%). The mean 60-min postoperative temperature of patients receiving Orve + wrap® blanket was 36.2 and 36.3°C for the patients receiving Forced Air Warming. The predefined noninferiority margin of a mean difference in temperature of 0.3°C was not reached between the groups at 60 min. Additionally, there were no statistical differences between adverse event rates across these groups.
In the context of this study, warming patients with the Orve + wrap® was noninferior to Forced Air Warming. There were comparable rates of associated postoperative consequences of warming (shivering, hypotension, arrhythmias or surgical site infections), between the groups.
The Orve + wrap® potentially provides an alternative warming method to Forced Air Warming for patients requiring short-term postoperative warming. However, there are still a number of unknowns regarding the Orve + wrap® performance and further exploration is required.
确定 Orve + wrap®热毯的临床效果和安全性。
围手术期意外低体温是麻醉后护理病房的常见问题，会对患者的术后发病率产生重大影响。尽管该产品已商业化，但尚无关于 Orve + wrap®有效性的临床证据。
一项单中心前瞻性、开放标签、非劣效性随机对照试验。
接受择期手术的术后低体温（35.0-35.9°C）患者，在 PACU 期间随机接受 Orve + wrap®或强制空气加热。使用零热通量测温法每 10 分钟记录一次患者体温。本研究使用 CONSORT 扩展清单报告非劣效性和等效性试验。
2016 年 12 月至 2018 年 10 月期间，129 名患者被随机分为接受 Orve + wrap®毯子（n = 65，50.3%）或强制空气加热（n = 64，49.7%）的组。接受 Orve + wrap®毯子的患者在 60 分钟时的平均术后体温为 36.2°C，接受强制空气加热的患者为 36.3°C。两组之间在 60 分钟时未达到体温差 0.3°C 的预设非劣效性边界。此外，两组之间与加热相关的不良事件发生率没有统计学差异。
在本研究背景下，使用 Orve + wrap®为患者保暖与强制空气加热相比非劣效。两组之间与加热相关的术后后果（寒战、低血压、心律失常或手术部位感染）发生率相当。
Orve + wrap®可能为需要短期术后保暖的患者提供了一种替代强制空气加热的保暖方法。然而，关于 Orve + wrap®的性能仍有许多未知因素，需要进一步探索。
