Pupillometry and Somatosensory Evoked Potential in Cardiac Arrest

NCT04720482 | Unknown

• 1 other identifier: PASCA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Cardiopulmonary Arrest With Successful Resuscitation; Resuscitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NPi cut-off value that renders a false positive rate (FPR) of less than 5% for a bilaterally absent SSEP response.

  SSEP and pupillometry performed 48 hours after cardiac arrest

Other Outcomes (1)

• Predictive capacity for SSEP and NPi for death at 30 days and neurological outcome at hospital discharge

  Assessed from medical records within a month after cardiac arrest

Study Arms (1)

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; Diagnostic Test: Automated Pupillometry

Interventions

Somatosensory Evoked Potentials DIAGNOSTIC_TEST

SSEP performed bilaterally with stimulation of the median nerve

Also known as: Cortical N20 response

Comatose survivors of cardiac arrest

Automated Pupillometry DIAGNOSTIC_TEST

PLR quantified as NPi using a handheld automated pupillometer

Also known as: Neurological Pulpil index

Comatose survivors of cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

avd 96 CIVA Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

Related Publications (1)

• 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 Jul;65(6):852-858. doi: 10.1111/aas.13822. Epub 2021 Mar 29.

  PMID: 33735459 DERIVED

MeSH Terms

Conditions

Heart Arrest

Interventions

Evoked Potentials, Somatosensory

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Christian CA Rylander, MD, PhD

CONTACT

+46313421096; christian.rylander@vgregion.se

Meena K Thuccani, Med. Lic

CONTACT

+46709282625; meena.thuccani@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: January 22, 2021
• Study Start: February 3, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)