Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Comparison of thermal imaging of extremity with and without fracture
研究概览
简要总结
The overall objective of this study is to (1) determine whether thermal imaging can be used during an acute trauma patient's secondary or tertiary survey to identify injury sites with an underlying fracture, and to (2) investigate whether thermal imaging can predict those patients whose fractures will result in a non-union.
详细描述
Human subjects will be enrolled into the study from NYU Langone Health and Bellevue Hospital Center. When orthopaedic surgery is consulted for management of a fracture, the patient will be offered enrollment into the study. The collected data will be assigned a letter and number associated for references with the patient's age, type of fracture, and time since original injury to thermal imaging scan. If any patient receives a thermal imaging scan at their initial injury evaluation, then he or she will also receive thermal imaging scans at all follow-up appointments to track changes in temperature over the healing process. No obtunded or unresponsive patients will be enrolled into the study. The goal will be to have to thirty patients enrolled into both acute fracture and non-union arms of the proposal for a total of sixty subjects. Age, gender, ethnicity, smoking status, medical history, and surgical history will be recorded for future confounding analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 to 95
- •Have fracture injury
排除标准
- •Subjects suffering from a hypothermia- or hyperthermia - related illness or other environmental exposure-type illness
- •Those with a concomitant fracture
- •Subjects with no specific medical history or surgical history
- •Subjects who cannot provide informed consent
研究组 & 干预措施
Acute fracture specific
The FLIR E95 camera will be used for the study. The injured extremity will be scanned with the thermal camera and a second scan will be performed on the non-injured extremity to provide an internal control for any differences in room temperature and humidity. Prior to scanning, both the injured and non-injured extremity will remain uncovered for 10 minutes, about the length of an average office visit, and the areas to be scanned will remain free from contact by the patient or interviewer during this time period. The camera will be held 2 feet away from the extremity at a 90º angle to limit reading contamination from objects other than the patient.
干预措施: FLIR E95 camera (Behavioral)
结局指标
主要结局
Comparison of thermal imaging of extremity with and without fracture
时间窗: through study completion, an average of 18 months
The FLIR E95 thermal imaging camera will be used to obtain a temperature evaluation of the injury site. The extremity with the underlying fracture will have a higher temperature reading when compared to the contralateral extremity without a fracture. Thermal imaging was selected for the proposed work due to its feasibility and potential to be a useful tool in the acute trauma setting. A thermal imaging camera detects infrared radiation and converts it to visible light. The FLIR E95 utilizes a class two laser with an output power below 1mW and this laser is considered safe without a skin or materials burn hazard unless a person deliberately stares into the beam
次要结局
- Change in thermal imaging predicting non-union(through study completion, an average of 18 months)