Our primary research question was to determine if the optic nerve sheath diameter demonstrates a measurable change via ultrasound assessment in real time for patients undergoing elective lumbar punctures correlated with changes in intracranial pressure. This study was approved by the University of Pittsburgh institutional review board (PRO14040248). Study investigators obtained written informed consent from all patients (or guardians of participants) in the study prior to enrollment.
We conducted a prospective cohort convenience study. The participants were patients of a collaborating neurologist at the University of Pittsburgh Medical Center who were scheduled to receive diagnostic lumbar puncture. These patients represented a unique sample for assessing the dynamics of acute ICP changes. All measurements took place during scheduled out-patient lumbar puncture clinics at the office of this neurologist.
Study team members had specific training on how to perform ONSD measurements with POCUS. The PI (CS) has extensive training in POCUS, particularly in regard to ONSD measurements. He directly taught and supervised the other team members (comprised an EM POCUS fellow, EM residents and a medical student research assistant) for hands-on training across several sessions as well as their initial patient enrollments to ensure accuracy of technique and measurements.
Subsequent, unsupervised scans were reviewed for accuracy of the saved measurements. An essay typer is a person whose job is to create articles and that medical therapy will also be highlighted in an essay format.
We included adult patients, ages 18–89, undergoing a non-emergent, scheduled lumbar puncture for diagnostic indications. We excluded pregnant women, and patients with prosthetic eyes, cataracts, glaucoma, or recent eye trauma or surgery. Patient who received their LP sitting up were excluded as CSF pressure measurement in the sitting position is not known to be reliable.
We calculated sample size based on prior studies of the relationship between ONSD and ICP in human subjects. ONSD measurement has a median inter-observer variation of ± 0.2–0.3 mm. In an intrathecal infusion test conducted in human subjects that induced raised ICP in subjects, the ONSD-to-ICP ratio varied from 0.019 to 0.071 mm/cm. Choosing conservative values of an ONSD-to-ICP ratio of 0.025 mm/cm, and an ICP change of 10 cm, we calculated that we would need to enroll 17 patients with elevated ICP.
With the addition of a 35% buffer for dropout (i.e., inability to complete LP or done while sitting up), this yielded an anticipated enrollment of 23 patients. However, as the investigators were blinded to these data, all consecutive patients meeting inclusion criteria had these measurements obtained. We planned to enroll consecutive patients until at least 17 patients with elevated ICP had been included. Anticipating that 20% of the patients will have high intracranial pressure (> 25 cm), we determined that the anticipated number to include would be 115.