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临床试验/NCT04637932
NCT04637932已完成不适用

Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy

Eylem Yaşar2 个研究点 分布在 2 个国家目标入组 61 人开始时间: 2020年11月20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
61
试验地点
2
主要终点
complication of percutan dilatation tracheostomy procedure.

研究概览

简要总结

In this study, our primary goal is to compare whether there is any difference in the complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of processing time.

详细描述

Following the approval of Muğla Sıtkı Koçman University Clinical Research Ethics Committee, 61 cases over the age of 18 who were scheduled for elective percutaneous dilatation tracheostomy in intensive care units were included in the study.

Elective percutaneous dilatation tracheostomy cases were randomly divided into two groups. Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.

In the endotracheal tube group, which is a conventional method, after entering the trachea with percutaneous technique, the intubation tube was removed before dilatation and percutaneous dilatation tracheostomy was performed with the Seldinger method.

In the pro-seal laryngeal mask group, the fiberoptic bronchoscope was advanced with a pro-seal laryngeal mask, and after the correct position was achieved, percutaneous dilatation tracheostomy was performed using the Seldinger Method.

Arterial blood pressure, oxygen saturation, heart rate, arterial blood gas, mechanical ventilation mode, positive end expiratory pressure and mean airway pressure values were recorded before and 30 minutes after the procedure.

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
Quadruple (Participant, Care Provider, Investigator, 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

  • hospitalized in intensive care units of our hospital and planned for elective percutaneous dilatation tracheostomy were included in the study.

排除标准

  • history of cervical trauma,
  • high-pressure mechanical ventilation (inspiratory pressure above 40 cmH2O),
  • pulmonary edema,
  • acute respiratory distress

结局指标

主要结局

complication of percutan dilatation tracheostomy procedure.

时间窗: 7 days

blood gas analysis, physical examination, lung auscultation, hemodynamics parameters

次要结局

  • processing time.(minutes)

研究者

发起方
Eylem Yaşar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eylem Yaşar

Muğla Sıtkı Koçman Universty

Muğla Sıtkı Koçman University

研究点 (2)

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