Intracranial Pressure Clinical Trial
Official title:
Correlation Between Intracranial Pressure as Measured by Lumbar Puncture Manometry and Percentage Body Fat as Measured by Air-displacement Plethysmography
Background: It has already been established that there is a weak positive relationship
between increased intracranial pressure (ICP), as measured by lumbar puncture manometry, and
increased Body Mass Index (BMI). This is also observed clinically in some patients with
idiopathic intracranial hypertension, who typically have raised BMI. The relationship
between BMI and percentage body fat is non-linear, especially at BMI > 40. The Bod Pod
device enables non-invasive body composition profiling, including accurate calculation of
percentage body fat, without the use of radiation.
Aim: To examine the relationship between intracranial pressure as measured by lumbar
puncture manometry and percentage body fat as measured by air-displacement plethysmography
(Bod Pod)
Methods: 100 patients undergoing routine diagnostic and therapeutic lumbar punctures for a
variety of non-emergency neurological conditions will be recruited. Cerebrospinal fluid
opening pressure will be measured using standard manometry techniques. Blood pressure,
height, weight, collar size, waist size and hip size will be measured. Body composition
profiling will be carried out using the Bod Pod.
Patients due to attend the elective lumbar puncture clinic will be contacted by letter
beforehand (at least a week) and provided with an information sheet about the this study.
Neurology patients are referred to the lumbar puncture clinic as part of their diagnostic
work-up. The clinic takes place every Friday on the neurology ward and is run by the MS
nurse consultant who does the procedure.
Patients agreeing to take part in the study will have a lumbar puncture as normal. Before
removing a small volume of spinal fluid (cerebrospinal fluid or CSF), the investigators
routinely measure spinal fluid pressure using a manometer (pressure gauge). This is
important because it indirectly tells us what the pressure is within the brain (intracranial
pressure or ICP). Samples of CSF and blood may be needed as part of NHS patient care, but no
additional samples will be needed for this study. The investigators will, however, take some
additional measurements during the visit, which won't take more than an extra 5 minutes.
These will include: weight and height; measures of neck, waist and hip circumference, using
a standard measuring tape; and blood pressure before and after the lumbar puncture. The
whole visit will be 45-60 minutes.
Patients agreeing to have body composition assessment in the Bod Pod device will be
scheduled for assessment at the School of Sport Sciences at the University of
Gloucestershire (Oxstalls campus) in the two weeks following lumbar puncture. The
investigators will also contact patients prior to the appointment to confirm this. The
university is a five minute drive from the hospital and can easily be accessed by public
transport. Temporary parking permits for use in the university car park will be provided
where necessary. At the university body composition will be assessed in the Bod Pod device
by one of the trained technicians. The device consists of a small enclosed chamber, in which
the patient sits. Changes in air volume allow calculation of body density and percentage
body fat. For the test, patients will need to bring some form of tight-fitting swimwear
(Speedos or underpants for men; swimming costumes for women, no bikinis). They will also be
required to wear a swimming hat (which will be provided). No metal objects should be worn
while in the Bod Pod. Prior to the test we may need to measure lung volume by asking the
patient to blow into a spirometer. This helps to calculate body density but is not always
necessary. The patient will then sit inside the Bod Pod (which is confined but non-invasive
and has a large window in the front hatch and a panic button if they want to alert the
technician) for about 3 minutes. During this time air displacement measurements are made and
some people may experience slight pressure in their ears, although this is not dangerous.
Male and female changing facilities are available and Bod Pod testing will be in a private,
screened-off area with only the technician present. Patients can also ask for a chaperone or
male/female technician if they prefer. This test will take about 15 minutes to complete and
patients will be given computer readout of their body composition.
A power calculation for the study indicates that approximately 100 patients will need to be
recruited. The investigators aim to recruit between 1 and 3 patients from the lumbar
puncture clinic per week and therefore predict that the study will be completed within 2
years.
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