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
- 尚未招募
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Post-operative shoulder pain
研究概览
简要总结
A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms:
- AIS with an insufflation pressure target of 9mmHg ±1mmHg; or
- AIS with an insufflation pressure target of 15mmHg ±1mmHg.
详细描述
The study is designed and powered to demonstrate superiority of the AIS at low pressure vs. at higher pressure on a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9mmHg ±1mmHg or to AIS with an insufflation target pressure of 15mmHg ±1mmHg.
Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, 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 surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subjects (<21 years of age)
- •> 20 kg in weight;
- •Capable and willing to provide parental Informed Consent and patient Assent;
- •Acceptable candidate for laparoscopic surgery;
排除标准
- •Active 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(international normalized ratio) ≥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%;
- •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)
- •Patients presenting with Ascites
结局指标
主要结局
Post-operative shoulder pain
时间窗: Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.
Severity of shoulder pain, which will be measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale or Wong-Baker FACES Pain Rating Scale, whichever is deemed more appropriate by the clinician assessing the patient.
次要结局
- Ease of anesthesia management(During procedure)
- Length of recovery room stay(Post-anesthesia care unit (PACU) discharge, up to 24 hours.)
- Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs?(During hospital stay up to 30 days)
- Pain severity and trend(Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days.)
- Rate of device-related events(During procedure)
- Pressure stability(During procedure)
- Length of Stay (LOS)(Until the time of hospital discharge, up to 10 days.)
研究者
Todd Ponsky
MD
Akron Children's Hospital