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临床试验/CTRI/2024/03/063974
CTRI/2024/03/063974尚未招募不适用

A Comparative study of endotracheal tube cuff pressure changes in supine vs prone position in neurosurgical patients using air and oxygen as anaesthetic gas mixture”

Seth G S Medical college and KEM Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年3月20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
120
试验地点
1
主要终点
To compare the Endotracheal tube cuff pressure changes in supine and prone position in neurosurgical patients.

研究概览

简要总结

Main function of Endotracheal tube(ET tube)cuff is maintain adequate sealing of airway to gastropharyngeal  aspiration & ensure the effective lung ventilation. Cuffed ET tube become the standard care for providing general anaesthesia because of better seal of trachea. Pressure inside the cuff should be good enough to prevent aspiration but not too high to obstruct the tracheal mucosa blood flow, it can also cause post op sore throat, hoarseness of voice and dysphagia. It is recommended that ET tube  cuff pressure should be maintained between 20 t0 30 cm of H2O. This study will compare the ET tube cuff pressure changes in supine or prone position in neurosurgical pateints while using oxygen & air as anaesthetic gas mixture. The cuff pressure will be  checked and adjusted at different interval of time  (After intubation, After final position, After procedure and Before extubation. Pressure volume loop completion  is also checked  at everytime. The volume of air required to inflate of deflate the ET tube cuff will also be recorded using 2cc syringe. post operatively patient is follow up for sore throat in 2 hours, 6 hours, 24 hours.

Primary aim of study  is to compare effect of positions(Supine and prone) on ET tube cuff pressure in neurosurgery pateints.

Secondary aim is incidence of change in ET tube  cuff volume required to keep the ET tube cuff pressure with in the allowable limit (20 to 30 cm of H2O) and to find out incidence of post operative sore Throat.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients whose age group is between 18 and 65years.
  • ASA grade 1 & ASA grade 2 patients.
  • Elective neurosurgical patients whose surgical.
  • position is either supine or prone in genaral anaesthesia.

排除标准

  • pregnant pateint emergency cases history of urti/lrti with in last 15 days pateint with thyroid swelling,tracheal pathologies.

结局指标

主要结局

To compare the Endotracheal tube cuff pressure changes in supine and prone position in neurosurgical patients.

时间窗: After intubation, After final position, At the end of procedure, Before extubation.

次要结局

  • 1.Incidence of change in endotracheal tube cuff volume required to keep the endotracheal cuff pressure with in the allowable limit (20 to 30 cm of H2O)(2.The post operative incidence of sore throat)

研究者

发起方
Seth G S Medical college and KEM Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shrikanta Oak

Seth G S Medical College and KEM Hospital

研究点 (1)

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