Quantitative Heat Loss With Laminar Air Flow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- heat loss
研究概览
简要总结
With approval of the IRB at the Cleveland Clinic and written informed consent, the investigators propose to study up to 20 healthy volunteers in the protocol below as this will allow for drop-outs. As the investigators believe that 10 volunteers will provide sufficient power to detect clinically-meaningful differences between laminar air flow treatments.
The study has been designed to find out whether heat loss increases significantly in laminar air flow operating rooms. Furthermore the investigators will find out whether active warming minimizes this heat loss. Increased heat loss increases the amount of perioperative hypothermia. It has been shown that perioperative hypothermia is associated with severe complications such as an increased incidence of surgical wound infections. On the other hand laminar air flow is explicitly used to decrease air-borne infections. Our study results will help to optimize thermal management of orthopedic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 45 years of age
- •Healthy male and female volunteers
- •ASA physical status I
- •Capable and willing to provide written informed consent
排除标准
- 未提供
研究组 & 干预措施
standard airflow and forced air warming
Subjects will lie on operating room bed with standard airflow and forced air warming.
干预措施: standard airflow with forced air warming. (Other)
laminar airflow with surgical drapes
Subjects will lie on operating room bed with laminar airflow device on and surgical drapes surrounding bed.
干预措施: laminar airflow with surgical drapes (Other)
laminar aiflow with forced air warming
Subjects will lie on operating room bed with laminar airflow on and warming forced air.
干预措施: laminar airflow with forced air warming (Other)
standard airflow with surgical drapes
Subjects will lie on operating room bed with standard airflow and surgical drapes surrounding bed.
干预措施: standard airflow with surgical drapes (Other)
结局指标
主要结局
heat loss
时间窗: 20 minutes
Defining the within-volunteer difference in heat flux between laminar air flow 'on' and laminar air flow 'off' as the primary outcome of interest, we will use two linear regression models to perform analyses, respectively, for active warming and no active warming settings. Ambient temperature and relative humidity will be adjusted for within this linear model if they are not adequately balanced between the four experimental scenarios, on average (as determined by standard univariable summary statistics).
次要结局
未报告次要终点