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Pupillometry and Somatosensory Evoked Potential in Cardiac Arrest (PASCA)

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ClinicalTrials.gov Identifier: NCT04720482
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Christian Rylander, Sahlgrenska University Hospital, Sweden

Brief 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.

Condition or disease Intervention/treatment
Cardiac Arrest Cardiopulmonary Arrest With Successful Resuscitation Resuscitation Diagnostic Test: Somatosensory Evoked Potentials Diagnostic Test: Automated Pupillometry

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Capacity of Neurological Pupil Index to Predict the Absence of Somatosensory Evoked Potentials in Comatose Survivors of Cardiac Arrest
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest Coma

Group/Cohort Intervention/treatment
Comatose survivors of cardiac arrest
Adult (>18 years) patients remaining comatose during intensive care 48 hours after cardiac arrest. All patients are submitted to both clinical routine measurements: pupillometry and somatosensory evoked potentials.
Diagnostic Test: Somatosensory Evoked Potentials
SSEP performed bilaterally with stimulation of the median nerve
Other Name: Cortical N20 response

Diagnostic Test: Automated Pupillometry
PLR quantified as NPi using a handheld automated pupillometer
Other Name: Neurological Pulpil index




Primary Outcome Measures :
  1. The association between NPi and bilateral absence of the cortical SSEP response. [ Time Frame: SSEP and pupillometry performed 48 hours after cardiac arrest ]
    ROC curve analysis


Secondary Outcome Measures :
  1. NPi cut-off value that renders a false positive rate (FPR) of less than 5% for a bilaterally absent SSEP response. [ Time Frame: SSEP and pupillometry performed 48 hours after cardiac arrest ]
    Analysed by stepwise crosstabulation of NPi values against absent cortical SSEP response.


Other Outcome Measures:
  1. Predictive capacity for SSEP and NPi for death at 30 days and neurological outcome at hospital discharge [ Time Frame: Assessed from medical records within a month after cardiac arrest ]
    Analysed as sensitivity, specificity and odds ratio



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult (>18 year old) comatose survivors of cardiac arrest admitted to the central intensive care unit at Sahlgrenska University Hospital in Gothenburg, Sweden.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720482


Contacts
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Contact: Christian CA Rylander, MD, PhD +46313421096 christian.rylander@vgregion.se
Contact: Meena K Thuccani, Med. Lic +46709282625 meena.thuccani@vgregion.se

Locations
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Sweden
avd 96 CIVA Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 413 45
Contact: Christian Rylander, MD, PhD    +46 31 342 10 00      
Principal Investigator: Christian Rylander, MD, PhD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Göteborg University
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Responsible Party: Christian Rylander, Associate Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04720482    
Other Study ID Numbers: PASCA
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases