A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OhioHealth
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Intraoperative Pneumoperitoneal Pressure (mmHg)
研究概览
简要总结
The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.
详细描述
The primary observation to be made is the level of carbon dioxide in the arterial blood, specifically when the patient is insufflated and deflated during the surgery. As a result of the consistent pressure that the AirSeal® system maintains, carbon dioxide will be absorbed in lower levels when compared to the standard of care systems in which fluctuations in intra-peritoneum pressure are seen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital
排除标准
- •Age < 18
- •Emergency surgery
- •BMI>44 or <18
研究组 & 干预措施
AirSeal System
This group receives the AirSeal System for intraoperative insufflation.
干预措施: AirSeal System (Device)
Standard Endopath
This group receives the Standard Endopath Trocar for intraoperative insufflation.
干预措施: Standard Endopath (Device)
结局指标
主要结局
Intraoperative Pneumoperitoneal Pressure (mmHg)
时间窗: Through end of procedure, an average of 156 minutes
Pneumoperitoneal pressure is the pressure exerted by air or gas in the abdominal (peritoneal) cavity. As the amount of air/gas increases, the pressure (mmHg) increases. The highest pressure that occurred during the procedure was compared between groups.
次要结局
- Carbon Dioxide Elimination (mmHg)(Baseline, 60 minutes, and at end of procedure, an average of 156 minutes)
- Intraoperative Arterial Blood Gas Oxygen (mmHg).(Baseline, 60 minutes, and end of procedure, an average of 156 minutes)
- Smoke Evacuation Quality(Through end of procedure, an average of 156 minutes)
- Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).(Baseline, 60 minutes, and at end of procedure, an average of 156 minutes)
- End-tidal Carbon Dioxide Pressure (mmHg)(Baseline, 60 minutes, and at end of procedure, an average of 156 minutes)
- Number of Ventilator Interventions(Through end of procedure, an average of 156 minutes)
- Procedure Time (Minutes)(Through end of procedure, an average of 156 minutes)