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临床试验/NCT06776900
NCT06776900招募中不适用

Video-assisted Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery: a Randomized Controlled Non-inferiority Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Time to intubation

研究概览

简要总结

Fiberoptic intubation was first described in the late 1960s and has since become an effective and well-established technique for airway management in awake, sedated, and anesthetized patients. This technique is especially useful in patients with known or suspected difficult airways such as those with limited mouth opening, reduced neck mobility, cervical spine injury, obesity, or an elevated risk for aspiration. The benefits of fiberoptic intubation also include fewer complications such as tooth injury and oropharyngeal bleeding; and the opportunity for optimal positioning of double-lumen tubes in patients undergoing thoracic surgery.

Anesthesiologists may be confronted with situations in which patients in a lateral position during surgery experience an accidental loss of airway patency. Intubation with direct laryngoscopy is more challenging and time-consuming in patients in the lateral position than in the supine position, particularly when there is an abrupt loss of airway patency, as demonstrated by prior research. These observations suggest that there is an unmet need for a reliable method of airway management for patients in the lateral position. Although the airway is of a larger caliber and ventilation renders less peak and better oxygenation when patients are in the lateral position, glottic view was unfavorable for intubation when Macintosh direct laryngoscope was used in this position. This could be the reason why such a procedure is unfamiliar in anesthesia even when it is the most needed in special situations. Flexible fiberoptic intubation in lateral position would be convenient in emergency situations like accidental extubation during surgery or inadequate regional anesthesia requiring general anesthesia. Flexible fiberoptic intubation in lateral position would be of significant assistance in neurosurgical patients especially those with occipital lesions and patients with difficult airway scores with limited mouth opening or neck extension.

After thorough literature review, we found that studies comparing flexible video-assisted fiberoptic intubation in the lateral versus supine position in pediatrics are lacking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged 2-10 years old.
  • •Both genders.
  • •ASA physical status I and II.
  • •Elective non-head-and-neck surgeries.

排除标准

  • •Refusal of patients.
  • •Head and neck surgeries or with history of previous ones.
  • •Head, neck and lung congenital deformities or pathologies.
  • •Patients with expected difficult intubation (based on examination).
  • •Patients with neuromuscular disorders.
  • •Hypoxia: defined as low oxygen saturation (SpO2) ≤ 95% on room air.
  • •Trauma patients or patients requiring emergency procedures.

研究组 & 干预措施

Supine group

Active Comparator

the patient will be kept in supine position with the head placed neutrally and a roll under the shoulders

干预措施: Supine position (Procedure)

Lateral group

Active Comparator

the patient will be positioned in the lateral position with head and neck physiologically aligned with head positioner. The dependent leg will be flexed at the hip and knee and the upper leg will be straight with a pillow between both legs

干预措施: Lateral position (Procedure)

结局指标

主要结局

Time to intubation

时间窗: 5 minutes from endoscope insertion between teeth

time from inserting the endoscope between teeth in the first intubation attempt, till successful display of end tidal carbon dioxide (ETCO2) waveform on capnography

次要结局

  • Rate of successful intubation at first attempt.(5 minutes from endoscope insertion between teeth)
  • Overall number of intubation attempts(5 minutes from endoscope insertion between teeth)
  • Incidence of complications(10 minutes from endoscope insertion between teeth)
  • Oxygen saturation(5 minutes from endoscope insertion between teeth)

研究者

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

Kareem Mohammed Assem Nawwar

Lecturer

Cairo University

研究点 (1)

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