NCT02002364Unknown不适用
A Comparison Between Flexible Single Use Endoscopes (Ambu aScopes) and Reusable Flexible Endoscopes Used as a Standard of Car When Intubation the Trachea Via an Aura-I Supraglottic Airway Device
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen
研究概览
简要总结
In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope.
We hypothesize that intubation is obtained equally effective with both types of flexible scopes
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
- None
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
- •ASA physical status 1-3 and evaluated pre-operatively and found suitable for tracheal intubation with a flexible optical scope via the SAD and scheduled for elective surgery/anesthesia and are conscious about their rights and consequences of participating in the study.
- •The patient must have one or two of the following predictors of difficult tracheal intubation:
- •Modified Mallampati score > 2 (= "no parts of the Uvula is visible")
- •a thyromental distance of less then or equal to 6.5 cms
- •Combined movement in head and neck < 90 degrees
- •Mouth-opening less the 4 cm (but must be larger then 2.5 cm)
- •Inability to protrude the teeth n the lower jaw beyond the upper incisors
- •BMI > 40 combined with a neck-circumference > 43 cms
- •Upper-lip-bite-test > 2
- •Previous difficult intubation or laryngoscopy (If more then two criteria are fulfilled the patient should be considered intubated awake instead. . But the upper-lip-bite-test and the prognation-beyond the incisors test represents a similar thing, namely the inability to sub-luxate the lower jaw, the if both these findings are positive it is only considered as counting for one.
排除标准
- •ASA physical status 4 or 5
- •contraindications for use of the SAD
- •Patients in whom intubation via a SAD has previously failed
- •Patients at risk of aspiration from the gastrointestinal channel
- •diseases in mouth, pharynx or larynx that precludes the use of a SAD
- •Patients in whom the cricothyroid membrane cannot be localized preanaesthetically
- •Patients in whom the doctor making the pre-anaesthetic evaluation finds in need of an awake intubation
- •Patients with possible Creutzfeldt-Jacobs disease or contraindication against the use of non-autoclavable equipment r risk of cross contamination with prions
结局指标
主要结局
Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen
时间窗: Measured during tracheal intubation at induction of anesthesia
次要结局
- Number of attempts at placing the supraglottic-airway-device (SAD)(From anesthesia induction and the following 10 minutes during securing of the airway)
- number of attempts at placing the flexible endoscope in the trachea(From anesthesia induction and the following 10 minutes)
- number of attempts at intubation(From anesthesia induction and during the following 10 minutes during airway management)
- Total time for placement of SAD and endoscopy and intubation(During induction of anesthesia and the following 10 minutes during airway management)
- The best glottic view obtained(After anesthesia induction and during the following 10 minutes during airway management)
- The ease of passage of the flexible endoscope via the SAD(During induction and airway management)
- The anesthesiologists' satisfaction with the procedure(During induction of anesthesia and within the 30 minutes hereafter)
- The quality of the endoscopically obtained image(During induction of anesthesia and the following 10 minutes during airway management)
- Postoperative sore throat, dysphonia or dysphagia one hour after extubation(AT the time 1 hour after extubation of the trachea)
研究者
Michael Seltz Kristensen
Consultant anaesthetist
Rigshospitalet, Denmark
研究点 (4)
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