Effect of Autonomic Dysfunction on Hemodynamic Instability During Per-oral Endoscopic Myotomy in Achalasia Patients: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Wobble of Systolic Arterial Pressure (SAP) during surgery
研究概览
简要总结
This prospective observational study aims to investigate the association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy under general anesthesia in achalasia patients. Per-oral endoscopic myotomy is known as the effective treatment for achalasia patients. During per-oral endoscopic myotomy, capnoperitoneum, capnomediastinum, and systemic CO2 accumulation can potentially impair hemodynamics. Moreover, it has been suggested that achalasia is associated with autonomic dysfunction. We hypothesized that patients with autonomic dysfunstion would esperience more hemodynamic instability during per-oral endoscopic myotomy compared with patients without autonomic dysfunction. In this prospective observational study, the autonomic function test will be performed before surgery, and advanced hemodynamic parameters will be recorded using EV1000 clinical platform (Edwards Lifesciences, USA) during surgery. The association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy will be analyzed.
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
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital
- •Patients aged ≥ 19 years
排除标准
- •Patients who are hemodynamically unstable before surgery
- •Patients in whom preoperative heart rate variability (HRV) test cannot be conducted
- •Pregnant women of breastfeeding women
- •Patients unable to read the informed consent form
结局指标
主要结局
Wobble of Systolic Arterial Pressure (SAP) during surgery
时间窗: During the intraoperative period, from the enterance to the operating room to the emergence of anesthesia
Wobble of SAP will be calculated according to the following formula. Performance Error (PE (%)) = (measured SAP-reference SAP) × 100/reference SAP Median performance error (MDPE (%)) = median {PEi, i = 1, 2, 3…, N} Median absolute performance error (MDAPE (%)) = median {\|PE\| , i = 1, 2, 3…, N} (N, number of measured SAP) Wobble (%) = median{\|MDPE - PEi\|, i = 1, 2, 3…, N}(N, number of measured PE) reference SAP = 120 mmHg
次要结局
未报告次要终点
研究者
Dong Woo Han
Professor
Gangnam Severance Hospital
