Development and validation of a prediction model for improving the diagnostic yield of brain imaging modalities in critically ill patients with nontraumatic encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- To elucidate the clinical predictors associated with a positive diagnosis on CT/MRI of the brain and to develop a nomogram prediction model for predicting a positive diagnostic scan.
研究概览
简要总结
After CTRI approval, the patients admitted to the ICU of All India Institute of Medical sciences, New Delhi from January 2020 to December 2024, who underwent CT /MRI head for evaluation of nontraumatic encephalopathy during their ICU stay will be screened for eligibility to meet the required sample size of 556. The demographical, clinical, radiological and laboratory data will be collected through a retrospective review of the ICU charts, laboratory and radiological reports from the electronic and inpatient medical records databases of our hospital. The indication for the CT/MRI requisition will be noted from the physician orders in the ICU charts. The neurological findings including any new focal neurological deficit (FND) and signs of raised intracranial pressure (ICP) will be noted from the physician’s notes. The radiological study outcomes and the treatment changes will be noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients admitted to the ICU who underwent CT or MRI head for evaluation of nontraumatic encephalopathy during their ICU stay in All India Institute of Medical sciences New Delhi from January 2020 to December 2024 will be screened for eligibility in the study.
- •Nontraumatic encephalopathy is defined as any new onset disturbance or worsening of baseline cognition or behavior and neurological function.
- •2.If multiple imaging is being done for the same patient then the outcome of each scan will be counted separately.
排除标准
- •1.Patients who did not undergo any CT/MRI of head during their ICU stay.
- •2.Patients with traumatic brain injury undergoing CT/ MRI head.
- •3.CT/ MRI scan in post-neurosurgical patients.
- •5.CT/MRI done as a follow-up of already established chronic neurological diseases.
- •6.CT/MRI scans performed for interventional imagery, such as a CT scan-guided procedures that the patient underwent.
结局指标
主要结局
To elucidate the clinical predictors associated with a positive diagnosis on CT/MRI of the brain and to develop a nomogram prediction model for predicting a positive diagnostic scan.
时间窗: After approval by CTRI, the data will be collected from ICU charts will be reviewed by retrospective chart review at the following timepoints: | 1.On the day of ICU admission for baseline data | 2. On the day of CT/MRI brain imaging and next day for the diagnostic yield and any treatment change event | 3.Till the last day of ICU stay for estimation of duration of ICU stay and mortality.
次要结局
- To evaluate the discriminating power of the developed prediction model.(Internal validation of the prediction model by splitting the entire dataset into development cohort & validation cohort at a 70:30 ratio.)
研究者
Meenupriya Arasu
All India Institute of Medical Sciences, New Delhi