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临床试验/CTRI/2025/07/089959
CTRI/2025/07/089959尚未招募不适用

Study of incidence of Perioperative respiratory Adverse Events(PRAE) in children aged 1 month to 12 years undergoing anaesthesia for surgeries involving ear, nose and throat and the risk factors associated with these Perioperative Respiratory Adverse Events, an observational study

Institutional Review Board Ethics and Reseach Committe Christian Medical College Vellore1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2025年7月12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
255
试验地点
1
主要终点
Development of Peri operative Respiratory Adverse Events during elective ENT surgeries in children of aged 1 month to 12 years

研究概览

简要总结

The incidence of Perioperative Respiratory Adverse Events (PRAEs) in children undergoing anaesthesia for ENT surgeries with risk factors associated with PRAEs will be studied.Children aged 1 month to 12 years are included.Informed consent is obtained prior to the surgery.

PRAEs are one of the most common complications after anaesthesia especially is paediatric age group.There is no enoiugh data abouth the same in South Indian population.Hence I would like to study this.

On the day of surgery, patient is taken up for surgery and after giving required anaesthesia, surgery will be commenced.At the end of surgery, extubated and shifted to recovery room.In recovery room, patient  will be observed for the development of respiratory adverse events and will be documented.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All children in the age group of 1 month to 12 years undergoing anaesthesia for elective ENT surgeries during a period of 1 year.

排除标准

  • Age less than 1 month and more than 12 years Parents denial and ASA physical status 4 and 5 Children with cyanotic heart disease.

结局指标

主要结局

Development of Peri operative Respiratory Adverse Events during elective ENT surgeries in children of aged 1 month to 12 years

时间窗: at baseline and after surgery (on same day)

次要结局

  • To study the risk factors associated with PRAE & validating "Score for prediction of Post oeprative respiratory complications in infants & children - SPORC C"(baseline & at the end of surgery on the same day)

研究者

发起方
Institutional Review Board Ethics and Reseach Committe Christian Medical College Vellore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Beaula P

Christian medical College, vellore

研究点 (1)

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