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临床试验/CTRI/2023/09/057898
CTRI/2023/09/057898尚未招募不适用

Comparison Of Videolaryngoscopy And direct laRyngoscopy for pedIatric oro-trAcheal iNTubation in an oncology ICU (COVARIANT): A Randomized Controlled Trial

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年9月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
First attempt success rate of orotracheal intubation in critically ill children with cancer.

研究概览

简要总结

The airway anatomy of the childrenis distinctive as compared with adults. The laryngoscopy and intubation inchildren are difficult because of restricted opening of the mouth,comparatively larger tongue and more cephalad larynx; also, the consumption ofoxygen is much higher in children as compared to the adults. Hence, limitedperiod is available for the intubation in children(1).The presence ofcongenital orofacial clefts distort the upper airway anatomy and associationwith wider palatal clefts, bilateral cleft lips, major nasal deformity, micrognathiaand receding mandible also increases the intubation difficulty.(2)

Particularly in cancer patient with pneumonia,radiation exposure, anterior mediastinal mass, orofacial tumors, bleedingtendency, distorted airway will further reduce the time window and increasedifficulty in tracheal intubation.

In VL, the scope incorporatesan integrated camera and display monitor, which is used for indirectlaryngoscopy to view the airway structures Since the view is obtained “around thecorner†the glottis is visualized better by the VL. A lesser quantity of forceis required at the base of the tongue during VL. Hence, the chances of localtissue injury and response to stress are reduced. Even though there is limited evidencethat the success of endotracheal intubation (ETI) is increased by VL, VL is nowmore.(3)

Since there are no comparative ICU studiesavailable for pediatric population, we decided to conduct this study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children age between 1 to 12 years admitted in ICU who need oro-tracheal intubation.

排除标准

  • a)Age < 1 year and > 12 years b)Unstable C-spine c)Cardiac arrest scenario d)Children on palliative care intent.

结局指标

主要结局

First attempt success rate of orotracheal intubation in critically ill children with cancer.

时间窗: Immediately post intubation

次要结局

  • 1.Time required for orotracheal intubation(2.Incidence of mild desaturation (92%))

研究者

申办方类型
Research institution and hospital

研究点 (1)

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