An open‐label, randomised controlled trial on the effectiveness of the Orve + wrap^® versus Forced Air Warming in restoring normothermia in the postanaesthetic care unit

<jats:title>Abstract</jats:title><jats:sec><jats:title>Aims and objectives</jats:title><jats:p>To determine the clinical effectiveness and safety of the Orve + wrap® thermal blanket.</jats:p></jats:sec><jats:sec><jats:title>Background</jats:title><jats:p>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®.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>A single centre prospective, open‐label, noninferiority randomised controlled trial.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Between December 2016–October 2018, 129 patients were randomised to receive either Orve + wrap® blanket (<jats:italic>n</jats:italic> = 65, 50.3%) or Forced Air Warming (<jats:italic>n</jats:italic> = 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.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>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)<jats:bold>,</jats:bold> between the groups.</jats:p></jats:sec><jats:sec><jats:title>Relevance to clinical practice</jats:title><jats:p>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.</jats:p></jats:sec>