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临床试验/CTRI/2022/09/045844
CTRI/2022/09/045844尚未招募不适用

Effect of intraoperative lung protective ventilation on cerebral hemodynamics (cerebral blood flow assessment using transcranial doppler, cerebral oxygenation by NIRS and ICPmeasurement using subdural catheter) in neurosurgical patients: a prospective observational study

SCTIMST1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年9月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
SCTIMST
入组人数
34
试验地点
1
主要终点
: comparison of cerebral oxygenation (NIRS), cerebral blood flow and intracranial pressure during conventional tidal volume ventilation and lung protective type of mechanical ventilation in patients undergoing neurosurgical procedures.

研究概览

简要总结

This study is prospective observational study which involves comparing changes in cerebral blood flow, cerebral oxygenation and ICP during lung protective ventilation in patients undergoing craniotomy and spine surgery.

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

  • Consenting adult patients undergoing craniotomy in supine position or anterior spinal surgery at Sree Chitra Tirunal Institute for Medical Sciences and Technology 2.Age 18-60 yrs.
  • ASA (American Society of Anaesthesiologists) class 1 and 2
  • GCS 15 prior to the surgery.

排除标准

  • 1.Patient refusal 2.Craniotomies other than supine position 3.Spine surgeries in prone position 4.Recent respiratory infection 5.Patients with chronic lung disease or pulmonary infections 1 month before surgery 6.Acute respiratory failure (pneumonia, acute lung injury, ARDS) 7.Emergency surgery 8.Patients with clinical signs (head ache, vomiting, confusion, papilledema, pupillary asymmetry) or radiological signs (midline shift > 1cm, presence of hydrocephalus) of raised intracranial pressure preoperatively.
  • 9.Long standing uncontrolled diabetes mellitus, systemic hypertension, cardiovascular disease, COPD 10.Patients with previous history of stroke, transient ischemic attacks 11.Obesity 12.ASA class 3,4,5 patients 13.Patients with subarachnoid haemorrhage, vasospasm 14.Pregnant and lactating mothers 15.Any abnormality in baseline NIRS and TCD values.

结局指标

主要结局

: comparison of cerebral oxygenation (NIRS), cerebral blood flow and intracranial pressure during conventional tidal volume ventilation and lung protective type of mechanical ventilation in patients undergoing neurosurgical procedures.

时间窗: 2 time points: conventional ventilation and lung protective ventilation

次要结局

  • : comparison of changes in systemic hemodynamics and dynamic ventilatory parameters during normal tidal volume and lung protective ventilation and its effect on cerebral hemodynamics in patients undergoing neurosurgical procedures.(2 time points: conventional ventilation and lung protective ventilation)

研究者

发起方
SCTIMST
申办方类型
Research institution and hospital

研究点 (1)

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