Comparative Study of Intra-abdominal Pressure Using Accuryn Monitoring System During Pulsed Field Ablation (PFA) for Treatment of Atrial Fibrillation and/or Atrial Flutter Under Sedation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia
研究概览
简要总结
The purpose of this study is to investigate the intra-abdominal pressure utilizing the Accuryn monitoring system during pulsed field ablation procedures in the electrophysiology lab compared to the type of anesthetic utilized.
详细描述
Intra-abdominal pressure (IAP) may play a role in patient outcomes during ablation procedures, as increased IAP could indicate potential adverse events. Such adverse events include aspiration of stomach contents, which can lead to respiratory issues post procedure and unplanned admission to the hospital post procedure. Potrero Medical has manufactured a foley based monitoring system that has been FDA cleared for the indication of measuring intra-abdominal pressure. The Accuryn monitor allows for continuous, real-time measurement of IAP and urine output, providing data that may enhance procedural safety and provide insights into any physiological responses unique to Pulsed Field Ablation (PFA). This study aims to compare PFA in terms of safety, efficacy, and IAP changes based on type of anesthesia received.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Adult patients receiving pulse field ablation procedures for standard of care treatment of atrial fibrillation and/or atrial flutter.
- •Eligible for Foley catheter placement with no contraindications to Intra-abdominal pressure (IAP) monitoring.
排除标准
- •Patients under the age of 18 will be excluded.
- •History of intra-abdominal surgery within the past 6 months.
- •Known contraindications to bladder catheterization or catheter ablation; history of prostate issues / Benign prostatic hyperplasia (BPH) or frequent urinary tract infections
- •Pregnant or breastfeeding individuals
- •History of chronic obstructive pulmonary disease (COPD) with home oxygen use
结局指标
主要结局
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia
时间窗: hour 2
intra-abdominal pressure during PFA when general anesthetic is utilized
Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation
时间窗: hour 2
intra-abdominal pressure during PFA when anesthesia is sedation
次要结局
- Incidence of Hiccups(hour 2)
- Amount oral secretions(hour 2)
- Number of post-operative intubations(hour 2)
- Total urine output(hour 2)
- Number of urinary tract infections(day 7)
- Number of unplanned admissions to the hospital(hour 2)