跳至主要内容
临床试验/NCT03272776
NCT03272776已完成不适用

A Multicenter Study of the Protector Laryngeal Mask in Non Paralyzed, Anesthetized Patients

Matilde Zaballos1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
280
试验地点
1
主要终点
Evaluate the number of attempts to insert of the LMA Protector

研究概览

简要总结

The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Protector Laryngeal Mask, a new second generation disposable supraglottic airway device, in patients undergoing elective surgery.

详细描述

Laryngeal masks (LM) and supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery.

LMA Protector (Teleflex Medical, Athlone, Ireland) is a new disposable SGD currently available for anaesthetic practice. It is made of silicone (with no latex in its composition) and shares some of the characteristics of the second generation SGDs (as the presence of a gastric access channel); however, it has an additional drainage channel, both channels terminate distally in a camera behind the mask cuff. The presence of two drainage channels ("male" and "female") increases the patient safety against regurgitation, both of distal gastric content and secretions located in the oropharyngeal region. The gastric access channel called "female" also allows the insertion of a nasogastric tube if required. These drainage channels are useful for diagnosing the correct position of the mask, since the observation of leaks or gas through it can help diagnose a displacement the mask.

LMA Protector is designed with a preformed anatomic curve, and the airway conduct has an elliptical cross section, which ends distally in the mask. This design follows the anatomy of the human airway, which facilitates the insertion of the device. The softness of the mask material allows easy insertion.

Doubts regarding the transmission of infectious diseases with reusable devices makes disposable devices such as LMA Protector, one of the most interesting devices for use in anaesthetic procedures that are usually performed with SGD.

Its characteristics in the design, composition by a smooth and atraumatic material, the presence of two gastric drainage accesses, with potential improved patient safety and its characteristic of being disposable suggests a significant expansion of its use in the coming years .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Surgery procedures usually performed with supraglottic devices.
  • ASA physical status I-III patients
  • Age 18-75
  • Signed inform consent

排除标准

  • Patients with known difficult airway
  • Patients with predicted difficult airway
  • Patients with increased risk of aspiration
  • Patient refusal to participate in the study.

结局指标

主要结局

Evaluate the number of attempts to insert of the LMA Protector

时间窗: The number of insertion attempts will be collected after anesthesia induction: 1 minute after the administration of propofol

Insertion attempts: from picking up the LMA Protector until the mask is placed into the patient mouth . (in numbers)

次要结局

  • Blood pressure during insertion of LMA protect(Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector)
  • Heart rate during insertion of LMA protect(Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector)
  • Oropharyngeal leak pressure of the LMA Protector(The Oropharyngeal leak pressure of the LMA Protector will be collected 5 minutes after the LMA Protector will be inserted)
  • BIS data(Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector (To evaluate the evolution of BIS values during insertion of the LMA)

研究者

发起方
Matilde Zaballos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matilde Zaballos

Anesthesiologist

Hospital General Universitario Gregorio Marañon

研究点 (1)

Loading locations...

相似试验

Multicenter Study of the Protector Laryngeal Mask | 临床试验