Comparison Between a Two Person Insertion With Lateral Rotation Technique of Laryngeal Mask Airway and the Classic Technique; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- the success rate of first attempt insertion of the LMA
研究概览
简要总结
The laryngeal Mask Airway was developed by Brain in 1981 and was available for clinical use in the United States by 1992 and has become very popular in routine medicine practice during 10 past years . LMA would serve as a choice to be used in the emergency situations even by the inexperienced users . Nowadays due to the increasing number of outpatient anesthesia and use of short-acting anesthetics almost without the use of any muscle relaxants requires an appropriate way for safe LMA insertion. As LMA insertion is generally performed blindly, clinicians are always in search of how to place and maintain the LMA in appropriate position.
详细描述
The standard method of insertion described by Dr. Brain is relatively easy, but sometimes it is impossible to insert the LMA with the standard method. However ease and time of airway management may be of special importance in emergent situations. Since its inception the LMA has undergone various modifications in type and material, which have made other methods of insertion possible, quicker and easier than the standard method. Intraoral manipulation can put the operator at risk of finger trauma and infection. However it is not possible to avoid intraoral manipulation when the standard technique or the classic LMA is used.
Therefore, many studies were seeking to find new methods to improve this technique. Hwang et al. first described The 90° rotation technique in adults that involves the following steps: the entire cuff of the LMA is inserted inside the mouth, rotated counter-clockwise through 90° and advanced until the resistance of the hypopharynx is felt . The use of this method is known to increase the success rate of insertion and decrease the incidence of blood staining of the LMA and sore throat compared to standard technique . Ghai et al. showed that rotational technique may be considered as the first technique of choice for classical laryngeal mask airway insertion in children . Lopez-Gil and colleagues reported a decrease in complications with the increase in the skill of the anaesthetist . PARVIZ et al. described a two person technique which performed by the technician who performs mouth opening and jaw thrust and the anesthesiologist who inserts the laryngeal mask. They considered it as a safe and effective method to establish a secure airway in anesthetized patients.. other studies have shown that LMA insertion with partially inflated cuff is easier than deflated cuff .
Current study will combine two methods of LMA insertion including two-persons and lateral rotational techniques and compare them with the standard insertion method regarding the success rate and incidence of 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
- Double (Participant, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA physical status grade I-II,
- •Age between 20-55 years old
- •undergoing minor surgeries under general anaesthesia using LMA
排除标准
- •patients at Risk of aspiration,
- •Mouth opening ˂ 2.5 cm,
- •BMI ≥ 35 kg/m2,
- •dental problems,
- •recent history of upper airway infection,
- •gastro-oesophageal reflux disease and
- •limited extension of the neck.
结局指标
主要结局
the success rate of first attempt insertion of the LMA
时间窗: from induction of anesthesia till patient connected to the ventilator.
confirmed insertion of LMA without need for further attempts.
次要结局
- LMA insertion time(up to 30 minutes post-induction of anesthesia)
- Heart rate (HR)(first 15 minutes post-induction of anesthesia)
- number of manipulations needed during insertion(up to 30 minutes post-induction of anesthesia)
- The incidence of complications following insertion of LMA(up to 1 day postoperative)
- The number of insertion attempts(up to 30 minutes post-induction of anesthesia)
研究者
Samar Rafik Mohamed Amin
lecturer of anesthesia and surgical ICU
Benha University