Evaluation of the Clinical Performance of Laryseal Clear Versus Ambu Aura 40 Laryngeal Mask Airway for Preschool Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Oropharyngeal Leak Pressure (OPLP) measurement:
研究概览
简要总结
Preschool children have specific anatomical and physiological characteristics which necessitates careful selection of an appropriate airway management device. Supraglottic airway devices can be used in anticipated or unanticipated difficult airway providing continuous oxygenation and ventilation with less hemodynamic stress response and less postoperative complications. So alternative techniques such as SADs have gained prominence in pediatric anesthesia both as primary airway and as a conduit for endotracheal intubation. So this study will evaluate the clinical performance of Laryseal Clear and Ambu Aura40 laryngeal mask airway in preschool children undergoing surgical procedures.
详细描述
This study will be conducted in the operating theaters of department of anesthesia, intensive Care and pain management in Zagazig University hospitals within 12 months.
Sample size:
Assuming the mean difference of oropharyngeal leak pressure is 24.83±10.52 cm H2O for Ambu Aura40 group and 18.1±5.1 cm H2O for laryseal clear group (SF Bell et al., 2012) (KP Kaur et al.,2024), so the sample size was calculated to be 48 (24 in each group) sample size was calculated using open epi at confidence interval 95% & power 80%. To compensate for the possible drop out the sample size will be increased by 10%.
Study population:
Selected patients will be divided into 2 groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent of patient's parents or guardians of the first degree.
- •American Society of Anesthesiologists (ASA) Class I or II.
- •BMI: 5-85% of the children of the same age and sex.
- •Patients with mallampati grade I, II
- •Type of anesthesia: general anesthesia expected to last for less than 2 hours.
排除标准
- •Emergency surgeries.
- •Expected difficult airway.
- •Patients with congenital or acquired airway malformations.
- •Patients with active upper respiratory tract infection at the time of surgery.
- •Patients with history of gastroesophageal reflux disease (GERD).
- •Patients with neuromuscular disorders affecting airway tone or respiratory function.
研究组 & 干预措施
Group L (LarySeal clear Group)
The laryseal laryngeal mask will be used as a primary airway management device during the surgical procedure.The head of the patient will be placed in the dorsiflexion sniffing position and a lubricated LMA of appropriate size (LarySeal, Flexicare medical Ltd., UK) will be inserted using the index finger digital method technique according to manufacturers guideline.
干预措施: LarySeal clear Group (Device)
Group A (Ambu Aura40 Group)
The Ambu Aura40 Laryngeal Mask will be used as a primary airway management device during the surgical procedure. Patient's head will be in neutral position, a lubricated Ambu® Aura40(Ambu A/S, Copenhagen, Denmark) of appropriate size will be inserted using the non rotational midline approach according to manufacturer's guideline.
干预措施: Ambu Aura40 Group (Device)
结局指标
主要结局
Oropharyngeal Leak Pressure (OPLP) measurement:
时间窗: after device insertion , 10 minutes later
The expiratory valve will be closed at 3L/min fresh gas flow and setting the upper pressure limit to 30 cmH2O , and the OPLP will be recorded as the peak airway pressure at which an audible gas leak occurs ( detected by auscultation over the neck just lateral to the thyroid cartilage). Head position will remain unchanged throughout the measurement to avoid variations in OPLP.
次要结局
- Time for SGAD insertion(periprocedural)
- Ease of device placement(periprocedural)
- Complication related to the SGAD(at PACU, 24 hour)
- Number of manipulations(periprocedural)