Pupillometry and Somatosensory Evoked Potential in Cardiac Arrest (PASCA)
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| ClinicalTrials.gov Identifier: NCT04720482 |
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Recruitment Status :
Recruiting
First Posted : January 22, 2021
Last Update Posted : January 26, 2021
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| Tracking Information | |||||||||
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| 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 |
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
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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.
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
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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| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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 |
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| Intervention |
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| 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:
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| 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] | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| 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 | ||||||||