Pupillometry and Somatosensory Evoked Potential in Cardiac Arrest

Cardiac Arrest Clinical Trial

— PASCA  

Official title:

The Capacity of Neurological Pupil Index to Predict the Absence of Somatosensory Evoked Potentials in Comatose Survivors of Cardiac Arrest

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720482
• Other study ID #: PASCA
• Status: Recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

>18-year-old comatose survivors of cardiac arrest with Glasgow coma scale < 9.

Exclusion Criteria:

return of consciousness before SSEP is performed; pregnancy; intracranial bleeding; traumatic brain injury; palliative care and lack of next of kin.

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Arrest With Successful Resuscitation
• Heart Arrest
• Resuscitation

Intervention

Diagnostic Test:
• Somatosensory Evoked Potentials
SSEP performed bilaterally with stimulation of the median nerve
• Automated Pupillometry
PLR quantified as NPi using a handheld automated pupillometer

Locations

Country	Name	City	State
Sweden	avd 96 CIVA Sahlgrenska University Hospital	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictive capacity for SSEP and NPi for death at 30 days and neurological outcome at hospital discharge	Analysed as sensitivity, specificity and odds ratio	Assessed from medical records within a month after cardiac arrest
Primary	The association between NPi and bilateral absence of the cortical SSEP response.	ROC curve analysis	SSEP and pupillometry performed 48 hours after cardiac arrest
Secondary	NPi cut-off value that renders a false positive rate (FPR) of less than 5% for a bilaterally absent SSEP response.	Analysed by stepwise crosstabulation of NPi values against absent cortical SSEP response.	SSEP and pupillometry performed 48 hours after cardiac arrest