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临床试验/CTRI/2021/11/038051
CTRI/2021/11/038051尚未招募不适用

Surgical Position Associated Intra-abdominal Pressure (IAP) changes in Neurosurgery : The SPAIN study

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年11月22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
80
试验地点
1
主要终点
To estimate the change of Intraabdominal pressure (IAP) from the baseline in different neurosurgical positions intraoperatively

研究概览

简要总结

This is a prospective single center observational study , where Intra abdominal pressure changes will be ,monitored  in different neurosurgical positions , like supine , prone, lateral  and sitting . Secondary outcome will be to the impact of intraoperative IAP changes in post operative hepatic and renal function &  on duration of ICU stay, hospital stay and neurological outcome ( using GOS ) . IAP will be measured using intravesical catheter technique Intraoperatively , and post operatively for 24 hour. Post operatively LFT and KFT will be done daily for 72 hours and renal injury status will be accessed using AKIN criteria.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult Patients of ASA I & II category (18 to 60 years of age) scheduled to undergo craniotomy for elective neurosurgical procedures.

排除标准

  • 1 Emergency neurosurgical cases.
  • 2 Patients with active abdominal pathology (eg: Liver disease and kidney disease, abdominal trauma etc) and/or preoperative hepatic or renal impairment.
  • 3 Contraindication to bladder catheterisation (eg: bladder surgery, injury, urethral strictures etc) 4 Preoperative haemodynamic instability.
  • 5 Pregnancy, Morbid obesity.

结局指标

主要结局

To estimate the change of Intraabdominal pressure (IAP) from the baseline in different neurosurgical positions intraoperatively

时间窗: O day and upto 3rd day

次要结局

  • To study the impact of intra-operative IAP changes with post-operative hepatic and renal function.(From the day of surgery to 3 post operative days .)
  • To study the impact of intra-operative IAP changes with ICU stay, hospital stay and the neurological outcome.(From the day of surgery till hospital discharge)

研究者

发起方
AIIMS New Delhi
申办方类型
Government medical college

研究点 (1)

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