Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04720482 |
| Other study ID # |
PASCA |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
January 2021 |
| Source |
Sahlgrenska University Hospital, Sweden |
| Contact |
Christian CA Rylander, MD, PhD |
| Phone |
+46313421096 |
| Email |
christian.rylander[@]vgregion.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Somatosensory Evoked Potentials (SSEP) and Pupillary Light Reflex (PLR) are key methods for
neurologic prognostication in comatose survivors of cardiac arrest. Both methods have low
false positive rates.Though they assess different functions of the brain, they should both be
sensitive to severe anoxic/ischemic injury from cardiac arrest. The aim of this observational
prospective study with an estimated recruitment of 50 patients is to examine the
interrelation between PLR and SSEP. PLR will be assessed by Neurological Pupil index (NPi)
and SSEP by the cortical N20 response to stimulation of the median nerve.
Description:
Background:
Anoxic/ischemic brain injury is the most common cause of death among comatose survivors of
cardiac arrest (CA). The neurological prognosis of these patients is assessed using the
multimodal prognostication model, which includes several methods. Somatosensory Evoked
Potentials (SSEP) and Pupillary Light Reflex (PLR) are key methods for prognostication, as
both have low false positive rates. Though they assess different functions of the brain, they
should both be sensitive to severe anoxic/ischemic injury from cardiac arrest. The primary
aim of the study is to describe the association between PLR quantified as the Neurological
Pupil index (NPi) and bilateral absence of the cortical SSEP signal in patients remaining
comatose after cardiac arrest. The secondary aim is to define a NPi cut-off value that
renders a false positive rate (FPR) of less than 5% for a bilaterally absent SSEP response.
Methods:
An explorative, prospective, observational, cohort of 50 adult (>18 years) comatose survivors
of CA admitted to the intensive care unit at Sahlgrenska University Hospital. The results
from routine SSEP performed > 48 hours after CA and PLR assessed using NPi calculated by
automated pupillometry are compared. Neurological outcome at hospital discharge is classified
using the modified Rankin Scale (mRS), where poor neurological outcome is defined by mRS 4-6.
Statistical analysis:
In order to find a significant difference in NPi of 0.7 with a power of 95% with two-sided
Fisher's non-parametric permutation test, 45 patients are needed assuming allocation 2:1 and
unequal SD in the groups 0.37 and 0.67, calculated from the IQR above, and significance level
0.01. To account for uncertainty within these estimates, we aim to include 50 patients with a
complete protocol.
A receiver operating characteristics curve (ROC-curve) will be used to find the NPi cut-off
values resulting in a false positive rate of less than 5% for absent SSEP to predict poor
neurological outcome. NPi values below the cut-off i.e., values consistent with poor outcome,
will be used to calculate the predictive value for SSEP at its given prevalence. Fisher's
exact test will be used to assess correlation between NPi and SSEP.
Discussion:
A clear correlation between the absence of cortical SSEP response and NPi values will permit
application of the adequate method to the individual patient. This may also enable
rationalisation of the multimodal assessment of the neurological prognosistication using a
smaller number of methods. In clinical practice, this may render the prognostication of
neurological function of comatose patients after cardiac arrest more accurate, as well as
more cost- and time efficient.
