Journal of clinical nursing · 2020
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.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Smith Neil, Abernethy Caroline, Allgar Victoria, Foster Louise, Martinson Victoria, Stones Elizabeth
Аннотация
AIMS AND OBJECTIVES: To determine the clinical effectiveness and safety of the Orve + wrap® thermal blanket.
BACKGROUND: 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®.
DESIGN: A single centre prospective, open-label, noninferiority randomised controlled trial.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
RELEVANCE TO CLINICAL PRACTICE: 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.
BACKGROUND: 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®.
DESIGN: A single centre prospective, open-label, noninferiority randomised controlled trial.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
RELEVANCE TO CLINICAL PRACTICE: 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.