Evaluation of Perioperative Core Body Temperature When Using Forced Air Warming or BARRIER® EasyWarm to Prevent Inadvertent Perioperative Hypothermia: An Open-label, Randomized Non-inferiority Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- The Difference in Core Body Temperature in the Two Treatment Groups.
研究概览
简要总结
This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively.
A non-inferiority, prospective, open-labelled, randomized, parallel investigation.
Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air warming. All subjects may receive rescue warming if their core temperature falls below 35.5°C. Rescue warming is optional and defined as the institution's standard of care to prevent hypothermia.
The primary purpose is to investigate if there is a clinically relevant difference in core body temperature between the two treatment groups.
A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each treatment group. The number includes a 30% drop-out rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form (ICF)
- •Male and female subjects aged 18 years and over
- •Subject scheduled for surgery with a minimum length of 60 minutes and a maximum length of 120 minutes
- •Scheduled surgery must be performed entirely under general anaesthesia
- •The subject must be able to receive temperature assessments via an oesophageal temperature probe when under general anaesthesia and via an oral thermometer before and after general anaesthesia as well as in the pre- and post-op area
- •The subject must have an oral temperature measurement of at least 36.0°C when first measured in the preoperative setting
- •The subject's scheduled surgical procedure must allow time to be warmed with a fully activated BARRIER® EasyWarm at least 30 minutes prior to induction of general anaesthesia
排除标准
- •Subjects with an American Society of Anesthesiologists (ASA) rating of 4 or greater
- •Known Diabetes with an HbA1c of more than 6 %
- •Relevant medical history (e.g., neuropathy, peripheral vascular disease, circulatory disorder or other) that presents risk to/of:
- •The subject's normal temperature regulation or
- •Perception of external temperature or
- •Subcutaneous lipoatrophy
- •Current use of concomitant medications that present relevant risk to/of:
- •The subject's normal temperature regulation or
- •Perception of external temperature or
- •Subcutaneous lipoatrophy
- •Epidural/Spinal anaesthesia
- •An oral temperature measurement ≥ 37.5°
- •Contraindications to the oesophagus temperature probe and oral thermometer
- •Presence of skin and soft tissue disorders in areas covered directly by the device in the two treatment groups (e.g. pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat)
- •Pregnancy
- •Severe non-compliance to protocol as judged by the investigator and/or Mölnlycke Health Care
结局指标
主要结局
The Difference in Core Body Temperature in the Two Treatment Groups.
时间窗: Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.
Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.
次要结局
未报告次要终点