Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Analysis of Standard deviation of all NN (SDNN) (ms)
研究概览
简要总结
Esophageal surgery is a complex surgery, with high post-operative morbidity and mortality. The incidence of complications associated with esophagectomy varies from 17% to 74%, in the literature. A section of vagus nerves is conventionally performed during esophagectomy for cancer, because of oncological margins. The vagus nerve is responsible for the parasympathetic innervation at the gastrointestinal level, but also at the cardiac and pulmonary level. The post-operative morbidity of these procedures could be linked in part to the bilateral section of the vagus nerves, because of their impact on the autonomous regulation of this vital functions. The main objective of the study is to find a modification of the sympathomimetic balance pre and post operatively, in patients undergoing esophagectomy.
详细描述
The sympathomimetic balance was measured using a Holter-ECG heart rate monitor. The parameters collected were used to calculate the variability of the heart rate, the high frequencies (HF, reflection of the parasympathetic system), the low frequencies (LF, reflection of the sympathetic system and the parasympathetic system) and the ratio // LF / HF (reflection of the sympathetic activity) thanks to Fourier analysis and the use of HRVanalysis software.
The measurements were taken at night, to overcome the great sympathomimetic variabilities due to external stimulations during the day: one night 3 month before surgery/before the first chemotherapy, one night between 2 and 4 weeks before hospitalization (remotely of possible chemotherapy), the night before the intervention (context of hospitalization and preoperative stress), one night between D7 and D10 (context of hospitalization, and distance from anesthetic drugs), one night at home between 4 and 8 weeks post-operative, and one night at home at 3 months post-operative.
The measurements were therefore not carried out the first nights following the intervention to overcome the anesthetic drugs that affect the balance of the autonomic nervous system.
A baroreflex measurement was carried out at the patient's entrance, the day before the intervention, during hospitalization, and the day of discharge. This measure was renewed at 3 months.
A measurement of patient activity was carried out preoperatively by wearing an actimeter watch for 1 week then renewed at 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Esophagectomy for cancer
- •written and oral agreement
排除标准
- •pregnant women,
- •patients with permanent atrial fibrillation,
- •patients with pace-maker
- •Patients under guardianship/curatorship
结局指标
主要结局
Analysis of Standard deviation of all NN (SDNN) (ms)
时间窗: day 7 to day 90
Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery
次要结局
- LF/HF ratio(after surgery : day 7, day 60, day 90)
- HF activity(after surgery : day 7, day 60, day 90)
- change in baroreflex(Day -1, Day 7, day discharge, day 90)
- modify the respiratory functional exploration(Day -30, Day 30, Day 60)
- physical capacity(Day-30, Day 30, Day 90)
- LF activity(after surgery : day 7, day 60, day 90)
- intraoperative pupillometry(during surgery)