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临床试验/NCT05108584
NCT05108584已完成不适用

The Intubation Procedure in COVID-19 Pandemic

Indonesia University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年11月19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
39
试验地点
2
主要终点
Total duration of the intubation process

研究概览

简要总结

The World Health Organization (WHO) declared COVID-19 as a pandemic in April 2020. COVID-19 first discovered in Wuhan, China in December 2019. As of May 4th, 2020, the total number of patients in China was 82,880, the number of deaths was 4,633, the death rate was 3.7%. In Indonesia, until May 4th 2020, there were 11,192 confirmed cases of COVID-19 with a total of 845 deaths. High transmission and death due to the severe acute respiratory syndrome coronavirus 2, patients with respiratory failure symptoms were suspected of having COVID-19 until declared negative. A potential and continuing threatening complication is acute respiratory failure. Patient with Acute Respiratory Distress Syndrome (ARDS) require both respiratory support and oxygen therapy. The choosing of endotracheal intubation is generally indicated in moderate to severe ARDS. Apart from respiratory failure, endotracheal intubation is also commonly performed in patients undergoing surgical procedures under general anesthesia for the management of the patient's airway. To prevent transmission to medical personnel, intubation is carried out using PPE according to the guidelines. Guidance for intubation in COVID-19 patients is recommended to use a video laryngoscope because it offers several advantages such as assisting glottis visualization and making the intubation operator more distant from the patient's mouth when compared to direct laryngoscopes. This study aims to see the effect of using PPE and the type of laryngoscope on the intubation process carried out in the COVID-19 pandemic. This study is a preliminary study aimed at seeing the effect size of the recommended PPE use on the process and success of intubation.

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 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 59 years old
  • Undergo elective or emergency surgery using general anesthesia with endotracheal tube
  • BMI below 30 kg/m2

排除标准

  • Airway difficulty as assessed by preoperative assessment
  • Critical patients with unstable hemodynamics
  • Suspected or confirmed COVID-19 with ASA 3-5

结局指标

主要结局

Total duration of the intubation process

时间窗: During the procedure

The sum amount of time needed to complete an intubation process that includes preoxygenation duration, neuromuscular blocker action, laryngoscopy duration, and endotracheal tube position confirmation with ultrasound

Safety as assessed by number of participants experiencing complications

时间窗: During the procedure

Number of participants who experience desaturation of oxygen (below 95%), airway injury, increased blood pressure (over 120/80 mmHg)

Success of intubation process as assessed by number of trials

时间窗: During the procedure

The sum amount of trials needed to successfully place an endotracheal tube to the respiratory system

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

Dita Aditianingsih

MD, PhD, Anesthesiologist Consultant

Indonesia University

研究点 (2)

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