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临床试验/NCT06219460
NCT06219460已完成不适用

A Comparison of Two Types of Face Masks: Cuffed and Uncuffed for Ventilation of Obese Patients

Medical University of Lodz2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Sealing of face masks measured by difference of inspired tidal volume and expired volume

研究概览

简要总结

Two types of face masks : cuffed and uncuffed were evaluated for artificial ventilation in obese patients. After induction to anesthesia patients were ventilated with both types of masks using anesthesia machine with the same settings: Tital Volume of 500 ml, respiratory rate of 12/min. The inspired and expired volume was measured using anesthesia machine volumeter, The difference between inspired and expired volume was counted. The comparison between two types of masks was performed taking into consideration several parameters: type of obesity, gender, age.

详细描述

The aim of the study was to determine which of the tested: cuffed or uncuffed face masks allows better replacement ventilation in obese patients.

The study was conducted on patients with the BMI over 39 kg/m2 Patients qualified for bariatric surgery were selected for this study according to the order of reporting to the surgery department. The study adopted a simplified assumption that the gynoid type of obesity most often concerns women, and the android type, i.e. abdominal obesity, most often affects men. Two face masks were used to compare the effectiveness of replacement ventilation: the cuffed and uncuffed . It was randomly chosen (by tossing a coin) which face mask would be used first. The induction of anesthesia was low-opioid, the patients were placed in the supine position with the head and trunk elevated by 25 degrees on a positioning pad. 100% oxygen concentration was used for active pre-oxygenation, the test mask was applied with one hand using the EC clamp technique. The masks were changed after four consecutive measurements for each type of mask. In order to objectify the measurement with the same tidal volume, a respirator was used with the same settings: Tidal Volume of 500 ml and respiratory rate of 12/min. Sealing was measured by comparing the inspired volume with expired volume, that is the amount of leakage generated by individual masks was assessed. The obtained data were analyzed with the Kolmogorow-Smirnov test and supplemented with the values of the Wilcoxona test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

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

  • scheduled for elective surgery under general anesthesia

排除标准

  • predicted difficult intubation
  • predicted difficult face-mask ventilation

结局指标

主要结局

Sealing of face masks measured by difference of inspired tidal volume and expired volume

时间窗: immediatethrough study completion

Sealing of cuffed or uncuffed masks during face mask ventilation in obese patients measred by anesthesia machine

次要结局

未报告次要终点

研究者

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

Tomasz Gaszynski

prof. dr hab.

Medical University of Lodz

研究点 (2)

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