A Comparison of Different Ventilation Strategies in Infants Using the Proseal™ Laryngeal Mask Airway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups
研究概览
简要总结
The purpose of this research study is to compare difference between breathing by oneself or with the partial help from an anesthesia machine in infants under general anesthesia.
Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated (improved breathing) with the help of the breathing machine versus breathing on their own.
详细描述
The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and allows the patient to breathe in and out adequately under general anesthesia (GA). The ProSeal™ laryngeal mask airway (PLMA™) is a specialized type of LMA with a design that permits the delivery of higher pressures to help the patient breathe in and out (ventilate) and also contains a channel to suction the stomach.
Infants under GA may breathe through a PLMA in different ways. Spontaneous ventilation consists of the infants breathing on their own through a PLMA™. Pressure support ventilation allows the patient to breathe on their own with additional help from the anesthesia machine. Pressure control ventilation allows the patient to breathe with the help of an anesthesia machine.
An infant undergoing surgery requires a deep level of general anesthesia which negatively affects their ability to ventilate. Thus, infants may not breathe in oxygen and carbon dioxide out adequately at this level of anesthesia and it may be beneficial to provide some level of support to enhance carbon dioxide exchange and to avoid hypoventilation.
This study will attempt to determine whether pressure support ventilation improves ventilation in infants undergoing outpatient 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
- 1 Month 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA (American Society of Anesthesiologists) physical classification of 1 or 2
- •Outpatient surgical procedures
- •Surgical procedure anticipated to be < 90 minutes
- •Subject age of 1 - 11 months (inclusive)
排除标准
- •Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation
- •ASA physical classification of 3, 4 or E
- •Premature infants or infants < 44 weeks post-conceptual age
- •Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia.
- •Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated.
- •Patients with tracheostomies- The individual's airway is already established and PLMA™ placement is not required.
结局指标
主要结局
Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups
时间窗: Up to 45 minutes
Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.
Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
时间窗: Up to 45 minutes
Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).
Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups
时间窗: up to 45 minutes
Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups
次要结局
- Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.(Up to 45 minutes)
- Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.(Up to 45 minutes)
- Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.(Up to 45 minutes)