Postoperative Effects of Phrenic Nerve Paralysis Induced During Resection Surgery: A Prospective Study With Electromyography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Diaphragmatic Electromyography
研究概览
简要总结
This prospective clinical study aimed to evaluate the postoperative effects of temporary phrenic nerve paralysis induced by intraoperative phrenic nerve crush during lung resection surgery. The study compared postoperative pulmonary function, diaphragm activity, and clinical outcomes between patients who underwent intraoperative phrenic nerve crush and those who did not. The objective was to assess the reversibility, safety, and clinical impact of temporary phrenic nerve paralysis in relation to postoperative residual pleural space and prolonged air leak.
详细描述
This prospective observational study was conducted at the University of Health Sciences, Konya City Hospital, Department of Thoracic Surgery, between September 2019 and March 2023. The study included patients who underwent lung resection surgery via muscle-sparing thoracotomy. In the intervention group, a controlled intraoperative phrenic nerve crush was applied to induce temporary phrenic nerve paralysis. In the control group, no phrenic nerve manipulation was performed.
The primary objective was to evaluate the postoperative effects and reversibility of temporary phrenic nerve paralysis using diaphragm electromyography (EMG) and pulmonary function tests (FEV1, FVC). Secondary objectives included the assessment of residual pleural space filling, prolonged air leak, chest tube duration, and length of hospital stay. The study also aimed to determine whether temporary phrenic nerve paralysis could help minimize postoperative residual pleural space and prolonged air leak without causing permanent functional impairment.
Ethical approval for the study was obtained from the Necmettin Erbakan University Faculty of Medicine Ethics Committee (approval number: NEU2019-1421). Written informed consent was obtained from all participants prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Participants, surgeons, and outcome assessors are aware of group assignment.
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 (18+) who underwent lobectomy via muscle sparing thoracotomy
- •Patients with adequate preoperative pulmonary function to tolerate lobectomy
- •Patients who provided written informed consent for participation.
- •Patients with available postoperative follow-up data, including EMG and pulmonary function tests
排除标准
- •Patients who underwent wedge resection, segmentectomy, pneumonectomy, or VATS procedures
- •Patients with previous phrenic nerve injury, diaphragmatic paralysis, or neuromuscular disorders affecting respiratory muscles.
- •Patients with incomplete postoperative follow-up or missing EMG/PFT data
结局指标
主要结局
Diaphragmatic Electromyography
时间窗: Preoperative; 3 weeks postoperative; 6 months postoperative
Quantitative assesment of diaphragmatic muscle activity using preoperative and postoperative EMG, recorded as motor unit action potential amplitude (mA) and duration (ms), to evaluate the degree of diaphragmatic dysfunction or recovery following intraoperative phrenic nerve compression.
Pulmonary Function Test - FEV1
时间窗: Preoperative; 3 weeks postoperative; 6 months postoperative
Spirometric assessment of forced expiratory volume in 1 second (FEV1) to evaluate postoperative respiratory performance and the potential impact of brief intraoperative phrenic nerve compression. FEV1 values will be recorded as absolute volume (L) and as percent predicted (% predicted). Comparisons will be made between groups at each time point.
Pulmonary Function Test - FVC
时间窗: Preoperative; 3 weeks postoperative; 6 months postoperative
Spirometric assessment of forced vital capacity (FVC) to evaluate postoperative respiratory performance and the potential impact of brief intraoperative phrenic nerve compression. FVC values will be recorded as absolute volume (L) and as percent predicted (% predicted). Comparisons will be made between groups at each time point.
次要结局
- Chest Tube Duration(Up to postoperative day 30)
- Length of Hospital Stay(Up to postoperative day 30)
- Prolonged Air Leak(Up to postoperative day 30)
研究者
Ferdane Melike Duran
Assistant professor of Thoracic Surgery
Konya City Hospital