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临床试验/CTRI/2019/01/016886
CTRI/2019/01/016886尚未招募不适用

COMPARATIVE EFFICACY OF CMAC MILLER VIDEOLARYNGOSCOPE Versus McGRATH MAC VIDEOLARYNGOSCOPE IN INFANTS UNDERGOING SURGICAL PROCEDURES

Department of Anesthesiology and Intensive Care1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Total intubation time

研究概览

简要总结

Airwaymanagement is integral partof general anaesthesia. Videolaryngoscopy (VL) is a new technique that hasthe potential to facilitate endotracheal intubation and decrease adverseconsequences. In adult population the advantages of VL over directlaryngoscopy (DL) have already been proven in several studies conducted in patientswith normal and difficult airways and critically ill patient. Incomparison to adults, intubation in infant and neonates is more challenging dueto various anatomical and physiological factors.Pediatric tracheal intubations (TI) may requiremultiple attempts, especially in neonates and infants and those with a historyof difficult airway and craniofacial anomalies. But, each additional attempt isassociated with increased chances of desaturation and airway morbidity.

VLfacilitates tracheal intubation during simulated/ clinically difficultintubation in adults, but it is not clear whether these findings translate tochildren.  Comprehensive clinical studies about the efficacy of paediatric VL for routine practice in difficult airways in children are inadequate and poorly documented. Well-designed,adequately powered randomized controlled studies are necessary to addressefficacy and safety of VL for endotracheal intubation in neonates.

CMACVL has compared favorably to the conventional DL for intubation in infants andchildren. Recently,McGrath MAC blade size 1 VL has been launched which is similar to conventionalMacintosh blade. There is paucity of studies comparing CMACMiller blade VL with McGrath MAC blade VL in respect to their clinicalefficacy in infants. So,we aim to establish whether the novel McGrath MAC videolaryngoscope providesequivalent performance as compared to CMAC Miller videolaryngoscope withrespect to time to intubation in infants. We will recruit a total of 140 neonates and infants as per our inclusion and exclusion criteria as mentioned above. After standard General anesthesia they will be intubated as per their group allocation. the observations will be recorded as mentioned above.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
0.00 Day(s) 至 12.00 Month(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists (ASA) grade I- III.

排除标准

  • Anticipated difficult airway or any such history Congenital anomalies of head and neck History of birth asphyxia Coagulation defect Any child with increased risk of aspiration.

结局指标

主要结局

Total intubation time

时间窗: after intubation

次要结局

  • Time to glottic view, tube insertion time, ETCO2 at the end of intubation, lowest SpO2 saturation reading during the intubation, POGO score and Modified Cormack-Lehane score, intubation difficulty scores & need for optimizing manoeuvres [OELM/ head extension], successful intubation at first attempt and total number of attempts, hemodynamic parameters, complications desaturation (SPO2 95%), trauma (lip, gum, airway), mucosal bleed or esophageal intubation.

研究者

发起方
Department of Anesthesiology and Intensive Care
申办方类型
Research institution and hospital

研究点 (1)

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