Cooling Vest May Reduce Heat Stress, Improve Thermal Comfort, and Preserve Cognitive Performance of Surgeons While Performing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Self-rated Thermal Comfort.
研究概览
简要总结
The investigators will propose a randomized cross-over trial using a uniform and strongly balanced 4-period design in which will include four operations for each surgeon. Surgeons will be randomized to 1 of 4 sequences: ABBA, BAAB, AABB or BBAA. The design is "uniform" in that each treatment appears the same number of times within each sequence (uniform within sequence) and if each treatment appears the same number of times within each period (uniform within each period). It is strongly balanced with respect to first-order carryover effects because each treatment precedes every other treatment, including itself, the same number of times
详细描述
The subjects will be randomly assigned to use either the CoolSource™ cooling vest (worn between scrubs) and a conventional surgical gown for each of 4 surgeries. Sequence of treatments within the subjects will be randomized (ABBA, BAAB, AABB or BBAA), and determined using the PLAN procedure in SAS, such that each surgeon will wear vest and non-vest twice. The sequencing will not be shared with any study personnel. Allocation for each case will be concealed with a web-based system that will be accessed only shortly before surgery.
The investigators will target an ambient temperature of 21°C ± 1°C, and try to maintain the same temperature of each of the four study cases for each surgeon. The CoolSource vest holds six reusable cooling packs located bilaterally on the shoulders, angled flank along the base of the rib cage, and along each side of the spine, mid-back. The vest will be donned over hospital-issued scrubs after all temperature sensing devices have been applied and before surgical hand scrubbing. The subjects will wear the vest throughout surgery, and for a few additional minutes while postoperative assessments are made (details below).
The weight of the disposable cooling vest is 1 kg which is evenly distributed over both shoulders. The cooling packs have an insulated cover to reduce condensation or sweating while seated inside the vest pocket. The flexible frozen reusable cooling packs will be inserted into each of the six pockets and the vest belt will be tied to hold the cooling packs securely. The disposable cooling vests will be discarded after each case, and the cooling packs returned to a freezer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgeons who perform elective major orthopedic surgery such as total hip and knee arthroplasties scheduled for 90 to 150 minutes at the Cleveland Clinic Main Campus.
- •Orthopedic surgeons ages of 25-65 years old, as body temperatures may be lower and less stable in the elderly (Waalen & Buxbaum, 2011), who operate frequently enough to participate in four cross-over cases.
- •Surgical helmet system is consistently worn for each of the surgeon's four cases, if used in the first case.
排除标准
- •Surgical cases that require surgeons to sit on stools during the procedure, which may impact temperature and energy expenditure.
- •- Surgeons who report having a recent illness within 24 hours prior to the surgery, symptoms producing a febrile condition;
- •Surgeons who worked the previous evening.
- •Surgeons who wear lead X-ray gowns.
研究组 & 干预措施
Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA)
Surgeons first performed one surgery with the cooling vest. On another day, they then performed one surgery without the cooling vest. Then on another day, they performed another surgery without the cooling vest. Then they finally performed one surgery with the cooling vest.
干预措施: Cooling Vest (Device)
Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA)
Surgeons first performed one surgery with the cooling vest. On another day, they then performed one surgery without the cooling vest. Then on another day, they performed another surgery without the cooling vest. Then they finally performed one surgery with the cooling vest.
干预措施: Without cooling vest (Device)
Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB)
Surgeons first performed one surgery without the cooling vest. On another day, they then performed one surgery with the cooling vest. Then on another day, they performed another surgery with the cooling vest. Then they finally performed one surgery without the cooling vest.
干预措施: Cooling Vest (Device)
Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB)
Surgeons first performed one surgery without the cooling vest. On another day, they then performed one surgery with the cooling vest. Then on another day, they performed another surgery with the cooling vest. Then they finally performed one surgery without the cooling vest.
干预措施: Without cooling vest (Device)
Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB)
Surgeons first performed one surgery with the cooling vest. On another day, they then performed another surgery with the cooling vest. Then on another day, they performed one surgery without the cooling vest. Then they finally performed another surgery without the cooling vest.
干预措施: Cooling Vest (Device)
Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB)
Surgeons first performed one surgery with the cooling vest. On another day, they then performed another surgery with the cooling vest. Then on another day, they performed one surgery without the cooling vest. Then they finally performed another surgery without the cooling vest.
干预措施: Without cooling vest (Device)
Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA)
Surgeons first performed one surgery without the cooling vest. On another day, they then performed another surgery without the cooling vest. Then on another day, they performed one surgery with the cooling vest. Then they finally performed another surgery with the cooling vest.
干预措施: Cooling Vest (Device)
Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA)
Surgeons first performed one surgery without the cooling vest. On another day, they then performed another surgery without the cooling vest. Then on another day, they performed one surgery with the cooling vest. Then they finally performed another surgery with the cooling vest.
干预措施: Without cooling vest (Device)
结局指标
主要结局
Self-rated Thermal Comfort.
时间窗: Immediately after surgery, within 10 minutes
Immediately after surgery, while still gowned, surgeons will rate their thermal comfort on a 0-10 Likert scale, with 0 representing extreme cold, 5 being thermal comfort, and 10 representing extreme heat. Two points on the 11-point Likert scale will be considered a clinically important difference.
次要结局
- Mean Core Temperature.(the sensor will be worn for a total of 90 minutes)
- Mean Skin Temperature(the sensor will be worn for a total of 90 minutes)
- Surgeons' Cognitive Performance, Measured With the C3B Battery.(Immediately after surgery, within 10 minutes)
- Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale.(Immediately after surgery, within 10 minutes)
- Surgeon' Perceived Fatigue Measured as 0 Representing Not Fatigued at All, 5 Moderately Fatigued, and 10 Total Fatigue & Exhaustion(Immediately after surgery, within 10 minutes)
- Surgeons' Perception and Amount of Sweat-soaked Scrub Clothing.(Immediately after surgery, within 10 minutes)