Correlation of Optic Nerve Sheath Diameter with External Ventricular Drain for measurement of Intracranial Pressure : An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Optic nerve sheath diameter(ONSD)
研究概览
简要总结
After getting institutional ethics committee approval, CTRI no. and written consent of
patient’s nearest of kin, patients will be included in this study.The demographic data (age ,gender,
race),Glasgow Coma Score(GCS),pupillary size and reactions, vital signs(heart rate ,respiratory
rate,blood pressure,temperature) and CT scan findings will be recorded on admission to ITU. The
verbal score of GCS will be modified for intubated patients using the formula: Derived Verbal
Score=−0.3756+Motor Score×(0.5713)+Eye Score×(0.4233)[17].All patients will be sedated with
midazolam and fentanyl administered intravenously, according to the treating physician’s
discretion. Following the decision to place an ICP monitoring device (EVD) (by the attending
intensive care physician and neurosurgeon), the patients will be enrolled in this study.Ocular US
will be conducted with SonoSite Micromax (SonoSite Inc., Bothell, WA, USA) ultrasonography
(USG) machine. Each patient will be examined in the supine position using a linear USG probe of
10-5 MHz frequency to get ONSD at 3 mm posterior to the ocular globe. The probe will be applied
on the temporal part of the closed upper eyelid with coupling gel [18] [19]. For each patient,
investigator will perform two measurements on each eye in transverse plane. The resulting four
measurements will then be averaged to yield a mean ONSD to minimise intraobserver variability.
Initial US ONSD will be measured before placement of the EVD catheter. The opening pressure
after placement of the EVD catheter, will be used as the initial ICP, and Intracranial hypertension
will be considered present when the patient will be having ICP above 20 mmHg for a period of
time greater than 5 min.The investigator measuring the ONSD with ultrasonography will be
blinded to invasive measurements of ICP. The need for urgent life saving surgery i.e.
Decompressive Craniectomy will also be noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
入选标准
- •Adult patients (aged ≥18 years)
- •Either Gender
- •Isolated Brain injury
- •Patients requiring EVD.
排除标准
- •Adult patients (aged ≥18 years)
- •Either Gender
- •Isolated Brain injury
- •Patients requiring EVD.
结局指标
主要结局
Optic nerve sheath diameter(ONSD)
时间窗: At baseline
次要结局
- Decompressive craniectomy(At 5 mins from 0 hours)
研究者
Ismail Shahidullah
Institute of Neurosciences, Kolkata
