Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Absence of duodenal lesions
研究概览
简要总结
For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. This leads to late MODS diagnostics preventing the implementation of adequate treatment.
Gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).
"MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients.
The probe will be used by intensivists on ICU patients with a risk of shock and requiring mechanical ventilation.
The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). This procedure will be used to assess the status of the gut mucosa prior to the placement of the APD probe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18 years of age or more,
- •Male or female,
- •ICU patient, on vasoactive amines, under mechanical ventilation,
- •Stable hemodynamic status,
- •Life expectancy expected to exceed 72 hours,
- •Length of ICU stay greater than 5 days,
- •Willing to participate and signed informed consent,
- •Affiliation to the French social security system.
排除标准
- •Pregnant or lactating woman,
- •Ongoing enteral nutrition,
- •Risk of gastrointestinal ischemia,
- •History of pharyngeal surgery surgery, esophageal surgery, radiotherapy of mediastinal area,
- •Known ear-nose-throat malignant disease,
- •Unexplored dysphagia,
- •Known recent gastrointestinal suture,
- •Esophageal varices,
- •Abdominal pain,
- •Unstable cervical fracture,
- •Moribund patient,
- •Active participation in another investigational protocol within the past 30 days,
- •Subject legally protected, under legal guardianship, deprived of his/her liberty by judicial or administrative decision.
结局指标
主要结局
Absence of duodenal lesions
时间窗: 24 hours
Duodenal lesions are defined as visible alterations of the duodenum.
次要结局
- Signal-to-noise ratio of the APD probe(24 hours)