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临床试验/NCT05772260
NCT05772260已完成不适用

Effect of Autonomic Dysfunction on Hemodynamic Instability During Per-oral Endoscopic Myotomy in Achalasia Patients: a Prospective Observational Study

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 41 人开始时间: 2023年4月3日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Woo Han

Professor

Gangnam Severance Hospital

研究点 (2)

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