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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

Tracking Information
First Submitted Date September 5, 2020
First Posted Date January 22, 2021
Last Update Posted Date January 26, 2021
Actual Study Start Date February 3, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 18, 2021)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 18, 2021)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 18, 2021)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Pupillometry and Somatosensory Evoked Potential in Cardiac Arrest
Official Title The Capacity of Neurological Pupil Index to Predict the Absence of Somatosensory Evoked Potentials in Comatose Survivors of Cardiac Arrest
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cardiac Arrest
  • Cardiopulmonary Arrest With Successful Resuscitation
  • Resuscitation
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Diagnostic Test: Somatosensory Evoked Potentials
  • Diagnostic Test: Automated Pupillometry
Publications * Lilja L, Thuccani M, Joelsson S, Nilsson J, Redfors P, Lundgren P, Rylander C. The capacity of neurological pupil index to predict absence of somatosensory evoked potentials after cardiac arrest-A study protocol. Acta Anaesthesiol Scand. 2021 Mar 18. doi: 10.1111/aas.13822. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 18, 2021)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christian CA Rylander, MD, PhD +46313421096 christian.rylander@vgregion.se
Contact: Meena K Thuccani, Med. Lic +46709282625 meena.thuccani@vgregion.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04720482
Other Study ID Numbers PASCA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Christian Rylander, Sahlgrenska University Hospital, Sweden
Study Sponsor Sahlgrenska University Hospital, Sweden
Collaborators Göteborg University
Investigators Not Provided
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date January 2021