Pilot Study to Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventilation (CMV) During Anesthesia for Robotic-Assisted Gynecological and Genitourinary Operative Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Optimal intra-operative ventilatory settings - Inspiratory Pressure
研究概览
简要总结
This is a pilot study to determine if pulmonary function (lung compliance and ventilation/perfusion matching) is improved using APRV during general anesthesia, compared to the standard CMV. APRV will be tested during anesthesia in 12 patients undergoing robotic-assisted gynecological or genitourinary surgical procedures for definitive cancer treatment, who will also receive CMV.
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
- •Participants must have histologically or cytologically confirmed gynecological or genitourinary cancer.
- •Subjects will have the physiologic reserve to undergo a robotic-assisted gynecological or genitourinary surgical procedure that uses anesthesia via Airway Pressure Release Ventilation and via Conventional Mechanical Ventilation.
- •Adults (≥18 years old)
- •ECOG performance status ≤
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Vulnerable subjects will not be enrolled for this study.
- •Patients who have COPD and are on oxygen at home or who have COPD requiring routine daily inhalers or daytime oxygen are excluded.
- •Patients who have history of major lung resection are excluded.
- •Patients with body mass index (BMI) >50 are excluded.
- •Patients with pulmonary infection within the past 2 months of screening are excluded.
- •The availability of oxygen to a fetus during this experimental procedure has not been established. Therefore, patients known to be pregnant per operating room (OR) policy will be excluded.
研究组 & 干预措施
APRV compared to CMV
APRV will be tested during anesthesia in 12 patients undergoing robotic-assisted gynecological or genitourinary surgical procedures for definitive cancer treatment, who will also receive CMV.
干预措施: Airway Pressure Release Ventilation (Other)
APRV compared to CMV
APRV will be tested during anesthesia in 12 patients undergoing robotic-assisted gynecological or genitourinary surgical procedures for definitive cancer treatment, who will also receive CMV.
干预措施: Conventional Mechanical Ventilation (Other)
结局指标
主要结局
Optimal intra-operative ventilatory settings - Inspiratory Pressure
时间窗: At surgery
Determination of the optimal intra-operative ventilatory settings for inspiratory pressure, expiratory pressure, inspiratory-expiratory time ratio and inspired oxygen concentration, that result in the best possible measured pulmonary function (i.e., compliance and gas exchange).
Optimal intra-operative ventilatory settings - Expiratory Pressure
时间窗: At surgery
Determination of the optimal intra-operative ventilatory settings for inspiratory pressure, expiratory pressure, inspiratory-expiratory time ratio and inspired oxygen concentration, that result in the best possible measured pulmonary function (i.e., compliance and gas exchange).
Optimal intra-operative ventilatory settings - Inspiratory-expiratory time ratio
时间窗: At surgery
Determination of the optimal intra-operative ventilatory settings for inspiratory pressure, expiratory pressure, inspiratory-expiratory time ratio and inspired oxygen concentration, that result in the best possible measured pulmonary function (i.e., compliance and gas exchange).
Optimal intra-operative ventilatory settings - Inspired oxygen concentration
时间窗: At surgery
Determination of the optimal intra-operative ventilatory settings for inspiratory pressure, expiratory pressure, inspiratory-expiratory time ratio and inspired oxygen concentration, that result in the best possible measured pulmonary function (i.e., compliance and gas exchange).
次要结局
未报告次要终点