A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation 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 children under general anesthesia.
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™ LMA (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.
Children under GA may breathe through a PLMA in different ways. Spontaneous ventilation consists of the children 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.
A child undergoing surgery requires a deep level of general anesthesia which negatively affects their ability to ventilate. Thus, children 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 children 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
- 12 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical classification 1,2 (Healthy or relatively healthy children)
- •Subjects scheduled for outpatient surgical procedures.
- •Surgical procedure anticipated to be < 90 minutes
- •Subject weight of ≤ 20 kg (44 lbs)
- •Subject age of 12 months to 5 years (inclusive)
排除标准
- •Inpatient
- •ASA physical classification of 3, 4 or E (sick children)
- •Risk of aspiration
- •Subjects with malignant hyperthermia or family history of malignant hyperthermia
- •Subjects with tracheostomies
研究组 & 干预措施
Spontaneous ventilation
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
干预措施: Spontaneous ventilation (Procedure)
Pressure support ventilation
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
干预措施: Pressure support Ventilation (Device)
Pressure control ventilation
Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.
干预措施: Pressure control ventilation (Device)
结局指标
主要结局
Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
时间窗: up to 90 minutes
Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups will be calculated by subtracting the mean of End-tidal Carbon Dioxide from the PSV group to the SV group
Mean Values of ETCO2 Between the PSV and PCV Groups
时间窗: up to 90 minutes
Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg
Mean Values of Tidal Volume Between the PSV and PCV Groups
时间窗: up to 90 minutes
Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg
Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
时间窗: up to 90 minutes
Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. Measured in mL/Kg and will be calculated by subtracting the mean of tidal volume from the PSV group to the SV group
Mean Values of ETCO2 in SV and PCV Groups
时间窗: up to 90 minutes
Mean Values of ETCO2 in SV and PCV groups reported in mmHg
Mean Tidal Volume Values Compared Between SV and PCV Groups
时间窗: up to 90 minutes
Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg
次要结局
- Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.(up to 90 minutes)
- Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.(up to 90 minutes)
- Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.(up to 90 minutes)