Clinical Evaluation of SmartPill Capsule for Investigation of Total Intestinal Transit Time and Intestinal Pathology in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Transit time
研究概览
简要总结
The purpose of this study is to evaluate the clinical usefulness of a capsule (SmartPill~) measuring pH, pressure and temperature from within the entire GI tract to determine gastric emptying time, combined small and large bowel transit time and total transit time. In addition, the Capsule will characterize pressure patterns and provide motility indices for the antrum and duodenum. It is believed that the condition of your digestive system can have a large impact on your overall physical health. Therefore,the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffered from traumatic or non-traumatic intracranial hemorrhage and were admitted to an intensive care unit (ICU) at University of Louisville Hospital
- •sedated and had tracheal intubation and mechanical ventilation
- •older than 18 years
排除标准
- •younger than 18 years
- •multiple injuries, especially abdominal trauma or inflammatory bowel disease
- •history of complicated abdominal surgery or unknown type of abdominal surgery
- •clinical evidence of ileus or suspected bowel obstruction
- •a pacemaker
结局指标
主要结局
Transit time
时间窗: 5 days
The subjects were followed from the time of placement of the capsule in the stomach until the capsule was viewed in the stool or abdominal X-rays revealed it had passed from the body
次要结局
未报告次要终点
研究者
Stefan Raugh
Principal investigator
University of Louisville