Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
研究概览
简要总结
This prospective randomized study will evaluate the effectiveness of laryngeal mask airway (LMA) versus endotracheal intubation (ETT) for patients undergoing laparoscopic inguinal hernia at CMH.
详细描述
This study aims to evaluate the effectiveness during general anesthesia of laryngeal mask airway versus endotracheal tube for laparoscopic inguinal hernia repair. There are limited pediatric literature evaluating the use of laryngeal mask airway for laparoscopic procedures compared with traditional endotracheal intubation. This study aims to add to this literature in providing information comparing the two techniques. The rationale for this study is to show that general anesthesia with laryngeal mask airway is an effective and non-inferior technique compared with general anesthesia with endotracheal intubation in pediatric patients undergoing laparoscopic inguinal hernia repair and may offer benefits in terms of efficiency of care and respiratory complications.
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 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic inguinal hernia repair.
- •Ages 12 months to 8 years of age
- •American Society of Anesthesiologists Physical Status Classification ASA 1 or 2
- •ASA 1- A normal, healthy patient
- •ASA 2- A patient with mild systemic disease
- •Elective with appropriate NPO status
- •English speakers
- •Spanish speakers
排除标准
- •Patients with current gastroesophageal reflux
- •Obesity (CDC >= 95th %ile)
- •Contraindications to study protocol medications
结局指标
主要结局
Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
时间窗: Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.
Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic
次要结局
- End-tidal Carbon Dioxide Measured by Capnography in mm Hg(Patients will have end-tidal carbon dioxide measured directly after placement of device, the first end-tidal carbon dioxide measurement recorded five minutes after the start of surgery, and immediately prior to removal of device, assessed up to 2 hours.)
- Peak Airway Pressure Will be Measured in cm H2O(Patients will have peak airway pressure measured directly after placement airway device, the first airway pressure recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.)
- Documentation of Laryngospasm Occurrence(Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.)
- Documentation of Oxygen Desaturation(Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.)
研究者
Emily Weisberg
Physican, M.D.
Children's Mercy Hospital Kansas City