Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

NCT01946802 | Completed Results

• 1 other identifier: H-1303-013-470
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Current guidelines recommend the use of sedatives and neuromuscular blocking agents to avoid shivering during therapeutic hypothermia in cardiac arrest victims. Therefore, it is difficult to detect seizure and the frequent or continuous EEG monitoring is recommended. However, it is difficult to follow this recommendation in most clinical situations due to the lack of specialized devices and persons. The purpose of this study is whether SEDline (frontal 4-channel EEG device) has a diagnostic value to detect seizure during therapeutic hypothermia in cardiac arrest victims.

Conditions

Cardiac Arrest

Keywords

Heart arrest; Cardiopulmonary resuscitation; Hypothermia induced; Seizures; Electroencephalography

Outcome Measures

Primary Outcomes (1)

• Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases

  Conventional EEG (gold standard for seizure detection) and SEDline monitoring will be conducted simultaneously for 30 minutes at During therapeutic hypothermia and rewarming (12 \~ 72 hours after cardiac arrest). Then, data retrieved from the conventional EEG and SEDline will be interpreted and analyzed for the presence of seizure.

  Within 72 hours after cardiac arrest

Secondary Outcomes (5)

• Sensitivity of SEDline for Seizure Detection

  Within 72 hours after cardiac arrest

• Specificity

  Within 72 hours after cardiac arrest

• Positive Predictive Value

  Within 72 hours after cardiac arrest

• Negative Predictive Value

  Within 72 hours after cardiac arrest

• Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection

  Within 72 hours after cardiac arrest

Study Arms (1)

Frontal 4 channel EEG

Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic out-of-hospital and in-hospital cardiac arrest.

Device: Frontal 4 channel EEG

Interventions

Frontal 4 channel EEG DEVICE

Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia

Also known as: SEDline, Masimo corporation

Frontal 4 channel EEG

Eligibility Criteria

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

Study Population

Comatose cardiac arrest survivors admitted to a 12-bed emergency intensive care unit of Seoul National University Hospital, Seoul, Republic of Korea.

You may qualify if:

• Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic out-of-hospital and in-hospital cardiac arrest.
• Cardiac arrest is defined as cessation of cardiac mechanical activity, confirmed by the absence of a detectable pulse, unresponsiveness, and apnea.

You may not qualify if:

• Age \< 18 years old
• Contraindication to therapeutic hypothermia: active life-threatening bleeding, septic shock, or refractory fatal arrhythmia..
• Intracranial pathology including hemorrhage or tumor
• Visible generalized seizure before the study enrollment
• Advanced directives to withdraw life-sustaining treatment
• No informed consent

Sponsors & Collaborators

• Gil Joon Suh: lead
• Masimo Corporation: collaborator
• Humed Co., Ltd: collaborator

Study Sites (1)

Department of Emergency Medicine, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (3)

• HOCKADAY JM, POTTS F, EPSTEIN E, BONAZZI A, SCHWAB RS. ELECTROENCEPHALOGRAPHIC CHANGES IN ACUTE CEREBRAL ANOXIA FROM CARDIAC OR RESPIRATORY ARREST. Electroencephalogr Clin Neurophysiol. 1965 May;18:575-86. doi: 10.1016/0013-4694(65)90075-1. No abstract available.

  PMID: 14296835 BACKGROUND

• Rossetti AO, Urbano LA, Delodder F, Kaplan PW, Oddo M. Prognostic value of continuous EEG monitoring during therapeutic hypothermia after cardiac arrest. Crit Care. 2010;14(5):R173. doi: 10.1186/cc9276. Epub 2010 Sep 29.

  PMID: 20920227 BACKGROUND

• Crepeau AZ, Rabinstein AA, Fugate JE, Mandrekar J, Wijdicks EF, White RD, Britton JW. Continuous EEG in therapeutic hypothermia after cardiac arrest: prognostic and clinical value. Neurology. 2013 Jan 22;80(4):339-44. doi: 10.1212/WNL.0b013e31827f089d. Epub 2013 Jan 2.

  PMID: 23284064 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Seizures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Since the SEDline system provides 4-channel-processed EEG monitoring in the frontal area, focal seizures could not be detected and spatial localization of the seizure might be difficult.

Results Point of Contact

• Title: Pf. Gil Joon Suh
• Organization: Seoul National University Hospital

suhgil@snu.ac.kr

82-2-2072-2196

Study Officials

• Gil Joon Suh, Prof

  Seoul National University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 20, 2013
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-03

Locations

KR (1)