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临床试验/NCT03852589
NCT03852589已完成不适用

Comparison of C-MAC Videolaryngoscopy-guided Proseal Laryngeal Mask Airway Placement vs Conventional Blind Technique: a Prospective Randomized Study

Inonu University2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
2
主要终点
First attempt success rate

研究概览

简要总结

The ProSeal laryngeal mask airway (ProSeal LMA; Intavent Orthofix, Maidenhead, UK) is a device with a double cuff to improve the seal and a drain tube to help prevent aspiration and gastric insufflation, facilitate passage of a gastric tube, and provide information about malposition. The manufacturer recommends inserting the ProSealTM LMA using digital manipulation or with an introducer tool, but both these techniques have lower success rates than the classic LMA.

This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.

详细描述

Airway management is one of the cornerstones for modern anaesthesia and is vital for all patients undergoing general anaesthesia. Supraglottic airway devices (SADs) are increasingly used for managing airways.

The ProSeal laryngeal mask airway (PLMA) (Laryngeal Mask Company, San Diego, CA, USA) is a supraglottic airway device with a larger cuff than the Classic laryngeal mask airway to produce a better seal. The PLMA is also equipped with a drainage tube to permit insertion of a gastric tube and evacuation of gastric content. The presence of the drainage tube reduces the risk of aspiration, which is the major concern of the Classic laryngeal mask airway, especially when the device is used with positive pressure ventilation. While a dedicated introducer (commonly known as an ''introducer tool'') is recommended by the manufacturer to facilitate insertion of the PLMA, difficulties can still be encountered during insertion. The PLMA insertion success rate at first attempt has been reported as 82-87%, which is lower than the insertion success rate of the Classic laryngeal mask airway.

Malpositioning of the PLMA is common in clinical practice because its soft cuff can fold over onto itself. Malpositioning of the device can result in severe leaks and even obstruction of the airway, with potentially negative outcomes for the patient. Although the incidence of complications(e.g. airway trauma, obstruction, regurgitation, gastric distension with mechanical ventilation) is likely to be higher with an incorrectly placed SAD, clinical airway obstruction can result from other causes, such as laryngospasm and transient closure of the glottis.

Many methods have been proposed to facilitate insertion of PLMAs, including insertion of a gastric tube,a suction catheter, or a gum elastic bougie into the drainage tube. These techniques help to prevent the PLMA soft cuff from folding over and help to decrease the incidence of malpositioning.

This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18- 65 years
  • Undergoing short surgical prcedures with general anesthesia using a PLMA
  • American Society of Anesthesiology score I-II

排除标准

  • Anticipated difficult airway
  • Risk of aspiration
  • Patients who refused written informed consent forms

研究组 & 干预措施

C-MAC Videolaryngoscope

Active Comparator

C-MAC Videolaryngoscope: An intubating device that is used for endotracheal intubation. Proseal laryngeal mask airway will be inserted with C-MAC Videolaryngoscope

干预措施: C-MAC videolaryngoscope (Device)

Blind

Active Comparator

Proseal laryngeal mask airway will be inserted with digital finger

干预措施: Blind (Device)

结局指标

主要结局

First attempt success rate

时间窗: From inserted PLMA to seeing meaningful end-tidal carbon dioxide levels up to 2 minutes

The PLMA will inserted into hypopharynx, the cuff will inflated with an appropraite volume of air. An effective airway will judged by a square wave on capnography.

次要结局

  • Insertion time(From inserted PLMA to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes)
  • Adverse Events(During the first 24 hour postoperatively)
  • Fiberoptic Score(After the PLMA insertion up to 5 minutes)
  • Airway Sealing Pressure(After the PLMA insertion up to 5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ülkü Özgül

Associate professor

Inonu University

研究点 (2)

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