A Single Center, Prospective, Randomized, Controlled Study To Evaluate Physician Preference Related to the Use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at Low VS. Higher Pressure for the Management of Pneumoperitoneum.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Incidence of shoulder pain
研究概览
简要总结
This study is designed to evaluate physician preference related to the use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of pneumoperitoneum.
详细描述
The objective of this study is to evaluate physician preferences related to use of the SurgiQuest AirSeal Insufflation System (AIS) used at low vs. higher pressures for maintaining pneumoperitoneum during laparoscopic/robotic surgical procedures.
The study is designed and powered to demonstrate superiority of the AIS used at low insufflation pressure (9±mmHg ±1mmHg) vs higher pressure (15mmHg ±1mmHg) in relation to a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9±1mmHg) or to AIS with an insufflation target pressure of 15±1mmHg.
Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, procedure time, the number of procedure interruptions, length of hospital stay, aspects of anesthesia management including end tidal CO2 and the frequency of adverse events. These outcomes will be evaluated in a controlled population undergoing laparoscopic/robotic surgery.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age;
- •Capable and willing to give informed consent;
- •Acceptable candidate for an elective, non-emergent laparoscopic/robotic surgery;
排除标准
- •Advanced refusal of blood transfusion, if necessary;
- •Active systemic or cutaneous infection or inflammation;
- •Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- •Uncontrolled diabetes mellitus
- •Known, significant history of bleeding diathesis, coagulopathy, Von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
- •Severe co-existing morbidities having a life expectancy of less than 30 days;
- •Currently involved in any other investigational clinical Studies;
- •Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- •Renal insufficiency (serum creatinine of > 2.5 mg/dl);
- •Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
- •Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
- •Patients presenting with Ascites -
结局指标
主要结局
Incidence of shoulder pain
时间窗: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Incidence of reported shoulder pain
次要结局
未报告次要终点
研究者
Cynthia Harris
Director of Clinical Studies
SurgiQuest, Inc.