Comparing the Effectiveness Between Air-Q Intubating Laryngeal Airway and Ambu® AuraGain™ Laryngeal Mask for Controlled Ventilation in Paediatric Patients: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- measure fibreoptic (FO) grade of laryngeal view
研究概览
简要总结
The aim of this randomized study is conducted is to evaluate the performance and safety of air-Q intubating laryngeal airway as primary airway device in various short surgical procedure in children compared to Ambu® AuraGain™ Laryngeal Mask. Current Supraglottic airway devices (SADs) available in are classic LMA (cLMA), proseal LMA (pLMA), supreme LMA (sLMA) and the newer is Ambu® AuraGain™laryngeal mask. As variety of newer SADs for children have emerged since their introduction in clinical practice, hope the outcomes of this study it help advancing our knowledge and acumen in selecting appropriate devices for paediatric population.
详细描述
JUSTIFICATION OF STUDY
In view of no clinical data is available evaluating the clinical performance and safety of air-Q and Ambu® AuraGain™ in children, therefore this prospective and randomized study is conducted. Most of previous randomized studies in term of safety did not compare the hemodynamic stability.Hope the outcomes of this study it help advancing our knowledge and acumen in selecting devices for paediatric population.
RESEARCH HYPOTHESES
- There is no difference in the ease of insertion (number of attempts and time of insertion) between air-Q and Ambu® Aura Gain™.
- There is no difference in the oropharyngeal leak pressure (OLP) between air-Q and Ambu® Aura Gain™.
- There is no difference in hemodynamic changes between air-Q and Ambu® Aura Gain™.
- There is no difference in the incidence of complications between air-Q and Ambu® Aura Gain™.
METHODOLOGY
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 1-6 years
- •Weight 10-30kg
- •American Society of Anesthesiologist (ASA) physical status class I and II
- •Any surgical procedures where supraglottic airway (SGA) management is appropriate
- •Duration of procedure within 2hours
排除标准
- •Active respiratory infection
- •Anticipated and known difficult airway
- •Lung disease requiring high airway pressure
研究组 & 干预措施
Ambu Aura Gain
Ambu Aura Gain supraglottic airway size 2 or 2.5 will be inserted once patients are paralyzed
干预措施: Ambu Aura Gain supraglottic airway (Device)
Air-Q
Air-Q supraglottic airway size 1.5 and 2.0will be inserted once the patients are paralyzed
干预措施: Air-Q supraglottic airway (Device)
结局指标
主要结局
measure fibreoptic (FO) grade of laryngeal view
时间窗: 5 minutes after insertion of the device when good tidal volume is achieved
Flexible fibreoptic scope is use to view anatomical alignment of the device to the larynx, 1cm proximal to the ventilating orifice
次要结局
- Blood pressure(Time from pre-induction until 5 minutes post insertion)
- Oxygen saturation (SpO2)(Time from pre-induction until 5 minutes post insertion)
- oropharyngeal leak pressure (OLP)(5 minutes after insertion of the device when good tidal volume is achieved)
- number of attempt(Throughout the insertion process up to 5 minutes post induction)
- Time of insertion(The time from which the device first being hold until successful insertion up to 5 minutes post induction)
- Heart rate(Time from pre-induction until 5 minutes post insertion)
- end tidal Carbon dioxide (EtCO2)(Time from pre-induction until 5 minutes post insertion)
- numbers of adverse effects of the devices as assessed by clinical observation(Throughout the stay in recovery bay within 30 minutes after operation)
研究者
Rhendra Hardy Mohamad Zaini
Dr
Universiti Sains Malaysia