A Prospective Randomised Controlled Trial of the LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 355
- 主要终点
- the successful placement of device in two groups
研究概览
简要总结
The study compares the LMA Supreme™ versus the Spritztube® tracheal cannula in anesthetized adult patients.
The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.
In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.
The investigators hypothesize that the LMA Supreme™ versus the Spritztube® tracheal cannula will similarly perform during anesthetized adult patients despite differences in their structural design.
详细描述
A new extraglottic airway device, the Spritztube® [tracheal cannula, Med Europe s.r.l], was developed combining the ability to perform both EAD ventilation and oro-tracheal fibreoptic intubation using the same device. The Spritztube® consists of a silicone cannula with two low-pressure cuffs: a proximal cuff, designed to seal the pharynx cranially of the epiglottis and a distal cuff, designed to seal the oesophagus. The positioning of this device requires the aid of a spindle, that keep the cuffs on the same line and it is rigid enough to allow the passage through oropharynx tissue. That can be inserted blindly as extraglottic device or through the use of direct laryngoscopy or fibroscopy as tracheal cannula.
The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.
In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
opening a sealed envelope, provided by an independent physician blinded to patient's allocation In addition, outcome assessor were blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists (ASA) physical status classification I, II, and III;
- •Age > 18 years
- •Elective surgery in the supine position
排除标准
- •Pregnancy
- •Age <18 years
- •Not eligibility for surgery
- •Predicted difficult airway management
- •Positive history for esophageal or pharyngeal diseases
- •Emergency surgery
研究组 & 干预措施
Spritztube®
The patients were randomly allocated to two groups by using computer-generated numbers.In Spritztube® group, Spritztube® was inserted into each patient after anesthesia induction.
干预措施: Spritztube® (Device)
LMA Supreme™
The patients were randomly allocated to two groups by using computer-generated numbers.In vgroup, LMA Supreme™was inserted into each patient after anesthesia induction.
干预措施: LMA Supreme™ (Device)
结局指标
主要结局
the successful placement of device in two groups
时间窗: Intraoperative
A successful intubation attempt was recognized if the breathing circuit was connected, the breath sounds over the lung were present and the End tidal CO2 trace was revealed.
次要结局
- Insertion time (in seconds)(Intraoperative)
- Easy to insert(Intraoperative)
- number of complications at insertion(Intraoperative)
- Number of attempts(Intraoperative)
- number of complications at removal(Postoperative)
研究者
Silvia De Rosa
Medical Doctor
St. Bortolo Hospital