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临床试验/NCT06484517
NCT06484517已完成不适用

Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients

Marmara University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022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
40
试验地点
1
主要终点
Success of intubation

研究概览

简要总结

Videolaryngoscopes improve laryngeal visualization in children under 3 years. In this study we aimed to compare Hugemed and McGrath videolaryngoscopes regarding their Cormach-Lehane (CL) and percentage of glottic opening (POGO) scores. Furthermore, tracheal intubation success rates, need for cricoid pressure and optimization maneuvers, and hemodynamic changes are compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
Double (Participant, Investigator)

入排标准

年龄范围
6 Months 至 3 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •total of 40 elective surgical patients under the age of 3, classified as ASA 1-3 risk group, who underwent general anesthesia with no anticipated difficult airway.

排除标准

  • •Patients who could not obtain parental consent, those classified as ASA 4 and above, individuals with serious cardiac and respiratory problems, and patients anticipated to have a difficult airway were not included in the study.

研究组 & 干预措施

The group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope.

Active Comparator

Before intubation, Cormack-Lehane score and percentage of glottis opening (POGO) score were recorded by applying direct and indirect laryngoscopy with the Macgreth videolaryngoscope. All tracheal intubations were performed by the same expert with over 10 years of experience in pediatric anesthesia.

干预措施: Hugemed Videolaryngoscope (Device)

For the group (Group H, n=20), the Hugemed videolaryngoscope was used.

Experimental

Patients were intubated using one of the appropriate blades numbered 1, 2, or 3 based on their height, weight, and age. After the induction of general anesthesia, patients underwent direct and indirect laryngoscopy with videolaryngoscopes. The Modified Cormack-Lehane score and Percentage of Glottic Opening (POGO) score were recorded, and orotracheal intubation was performed. Number of attempts, need for cricoid pressure, optimization maneuvers, success rate, and hemodynamic parameters of both groups were recorded.

干预措施: Hugemed Videolaryngoscope (Device)

结局指标

主要结局

Success of intubation

时间窗: Procedure (At the time of the intubation of the patient.)

Number of attempts of the intubation.

次要结局

  • Degree of hemodynamic changes(Procedure (At the time of the intubation of the patient.))
  • Percentage of glottis opening (POGO)(Procedure (At the time of the intubation of the patient.))
  • Need for optimization maneuvers(Procedure (At the time of the intubation of the patient.))
  • blood pressure(Procedure (At the time of the intubation of the patient.))
  • Success of intubation(Procedure (At the time of the intubation of the patient.))

研究者

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

Gamze Tanırgan Çabaklı

Dr.

Marmara University

研究点 (1)

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