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临床试验/NCT04730362
NCT04730362已完成不适用

Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging: a Randomized Controlled Trial

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Image quality of each MRI sequence

研究概览

简要总结

This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in improvements in image quality.

详细描述

Magnetic resonance image (MRI) is a frequently used imaging technique especially in oncological patients, where it is used for diagnosis, following up response to treatment and later for detection of possible recurrence. The main problem encountered with MRI is the long time required for completion of the imaging, during which the patient is required to lie still. Patients who are unable to lie still require sedation or general anesthesia (GA). Almost all pediatric patients are uncooperative, making GA, the standard of care for pediatric MRI.

Several general anesthetic techniques including airway management by endotracheal tube & various supraglottic devices (LMA) have been described. Choice of technique by anesthesiologist is influenced by the patient's age, craniofacial and airway anatomy, procedure duration, & illness acuity.

研究设计

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

盲法说明

Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ASA І and II patients
  • Age under 18 years .
  • The patient will need GA and patient Scheduled for MRI brain.

排除标准

  • Glasgow coma scale ≤ 8
  • Emergency patient with full stomach.
  • Distorted upper airway anatomy making intubation with GA mandatory.

研究组 & 干预措施

Control group

Active Comparator

20 patients in which a Guedel oral airway will be inserted for airway management and to conduct inhalational anesthetic through face mask fixed with harness to the head and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% .

干预措施: guedel airway (Device)

Control group

Active Comparator

20 patients in which a Guedel oral airway will be inserted for airway management and to conduct inhalational anesthetic through face mask fixed with harness to the head and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% .

干预措施: propofol bolus and then anesthesia sevoflurane (Drug)

supraglottic group

Active Comparator

20 patients in which supraglottic airway laryngeal mask airway (LMA) will be used and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% .

干预措施: supraglottic airway (Device)

supraglottic group

Active Comparator

20 patients in which supraglottic airway laryngeal mask airway (LMA) will be used and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% .

干预措施: propofol bolus and then anesthesia sevoflurane (Drug)

结局指标

主要结局

Image quality of each MRI sequence

时间窗: During general anesthesia of MRI investigation procedure

Image quality of each MRI sequence is evaluated by using a scoring system with the following scores: score of 1 (non-diagnostic), score of 2 (poor quality but some diagnostic value), score of 3 (average), score of 4 (good), and score of 5 (excellent).

次要结局

未报告次要终点

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Abdelfattah Abdelwadod

Mohammed Abdelfattah Abdelwadod

National Cancer Institute, Egypt

研究点 (1)

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