Head Position for Laryngeal Mask Air Leak and Performance in Paediatric Patients (Neutral, Sniffing and Beyond Sniffing Position): Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- leak volume in 3 different head position in every patient (1st position will be randomized)
研究概览
简要总结
The correct head position for airway management is considered as a mainstay of good clinical practice. The recommended head position for all patients is the horizontal position of the head with in tragus-to- sternal notch in line alignment. This could be achieved in infant (under two years) supporting the shoulder, neutral head positioning in children between 2-8 (12) years and with so called "sniffing position" (SP) in patients over 12 year by supporting the head (i.e. with pillow) to reach the proper alignment (tragus to sternal notch). Although, this could be considered as gold standard, there are currently insufficient high quality evidence-based data to confirm the association between the better laryngeal view during the direct laryngoscopy and tragus-to-sternal notch position. Recently, "beyond sniffing" position was described as further head elevation (compared to sniffing position) in adult patients. Beyond sniffing position was associated with superior laryngeal inlet visualization compared to standard sniffing position in common elective adult airway management (patients with suspected or confirmed difficult airway was excluded). The hypothesis of SNIFF LM trial is that the sniffing position or even beyond sniffing position could be associated with superior laryngeal mask performance (lower incidence of air leak, LM easier introduction) compared neutral position in paediatric patients undergoing elective paediatric anaesthesia
详细描述
Paediatric patients (between 2-18 years) undergoing elective airway management without predicted/confirmed difficult airway will be eligible for inclusion. The patients will be screened for eligibility during the preanaesthesia visit in anaesthesiology examination room. After informed consent the patients will be randomized into 3 groups (according to the induction head position) - neutral head position (without head elevation, head supported with the hollow foam circle to prevent side head movement), sniffing position (head support with inflatable pillow the reach the horizontal in-line alignment of tragus-to-sternal notch line) and beyond sniffing position (further 25% increase of head support compared to sniffing position). The randomization will be performed by the Institute of Biostatistics and Analysis in form of sealed envelopes. The group allocation will be 1:1:1. After fulfilling the inclusion criteria and obtaining the informed consent the patient will be randomized into 3 groups. Before anaesthesia induction the head of the patient will be positioned into the predefined position according to the results of randomization. The anaesthesia induction could be performer either inhalation or intravenous route. After anaesthesia induction, the laryngeal mask will be inserted in the selected position. After laryngeal mask insertion, stabilisation of vital signs and of anaesthesia depth, the measurement will be intiated within 5 minutes. After one minute of ventilation 3 leak volumes (inspiration - expiration tidal volume) together with the peak airway pressure (3 measurements) will be recorded (the mean volume and mean pressure will be analyzed). Patient´s head will be repositioned into the 2nd position and after one minute of ventilation leak volume and airway pressure will be recorded as previously described, after measurement, the head position will be repositioned into the 3rd positon and the measurement will be repeated. The incidence of 1st insertion attempt failure rate, incidence of laryngeal mask failure rate, incidence of the need for reposition will be recorded together with the incidence of airway related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Under general anaesthesia
入排标准
- 年龄范围
- 2 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-19 years
- •Informed consent
- •Elective airway management
- •laryngeal mask for airway management
排除标准
- •Outside the age limits
- •Decline to participate
- •Predicted or confirmed difficult airway
- •Cervical spine injury
- •limited access to head of the patient after anaesthesia induction (for the measuement purposes)
- •Intubation
研究组 & 干预措施
Neutral head position
Laryngeal mask will be inserted after anaesthesia induction in neutral head position
干预措施: Laryngeal mask insertion (Device)
Sniffing position
Laryngeal mask will be inserted after anaesthesia induction in sniffing head position
干预措施: Laryngeal mask insertion (Device)
Beyond sniffing position
Laryngeal mask will be inserted after anaesthesia induction in sniffing head position
干预措施: Laryngeal mask insertion (Device)
结局指标
主要结局
leak volume in 3 different head position in every patient (1st position will be randomized)
时间窗: 1 minute mechanical ventilation in predefined head position
leak volume in 3 different head position in every patient (1st position will be randomized) defined by the average leak obtained from 3 measurements in selected position
次要结局
- incidence of failed 1st attempt insertion rate(anaesthesia induction)
- incidence of the need for head reposition to obtain better airway seal in the 3 randomized head positions.(Intraoperatively)
- Leak pressure in 3 different head position in every patient (1st position will be randomized)(1 minute mechanical ventilation in predefined head position)
- Incidence of airway related complication(From anaesthesia induction until dismission from postanaesthesia care unit)
- incidence of overall laryngeal mask failure(anaesthesia induction)
研究者
Petr Štourač, MD
Clinical Professor
Brno University Hospital