Correlation of Optic Nerve Sheath Diameter with External Ventricular Drain for measurement of Intracranial Pressure : An Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Optic nerve sheath diameter(ONSD)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
Inclusion Criteria
- •Adult patients (aged ≥18 years)
- •Either Gender
- •Isolated Brain injury
- •Patients requiring EVD.
Exclusion Criteria
- •Adult patients (aged ≥18 years)
- •Either Gender
- •Isolated Brain injury
- •Patients requiring EVD.
Outcomes
Primary Outcomes
Optic nerve sheath diameter(ONSD)
Time Frame: At baseline
Secondary Outcomes
- Decompressive craniectomy(At 5 mins from 0 hours)
Investigators
Ismail Shahidullah
Institute of Neurosciences, Kolkata
