Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test

NCT02503878

Seizure

TERMINATED

Sedline EEG Guided Depth of Anesthesia

NCT05051982

Anesthesia Surgery

COMPLETED NA

Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

NCT03154879

Heart Arrest

UNKNOWN

SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation

NCT03128931

Anesthesia

TERMINATED NA

the Research of the Cerebral Protection Effects of Electroencephalogram (SedLine) During Carotid Endarterectomy

NCT03622515

Transient Ischemic Attack Acute Stroke Postoperative Delirium +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. Treatment of cardiac arrest victims Enrolled patients receive basic and advanced cardiac life support according to the 2010 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC).

After acquiring sustained return of spontaneous circulation (ROSC), the patients are immediately admitted to the ICU and are provided postresuscitation care including mild therapeutic hypothermia for 24 hours post-ROSC.

During therapeutic hypothermia, their core temperatures are maintained from 32 to 34°C.

Then rewarming is conducted (\< 0.25°C/hour) till core temperature 36.5°C. To avoid shivering, we use sedatives and neuromuscular blocking agents during the therapeutic hypothermia.
2. Conventional EEG Conventional EEG is conducted for 30 minutes at

1\) During therapeutic hypothermia and rewarming (within 72 hours after cardiac arrest) Then, the results are interpreted by a neurologist for the presence of seizure.
3. SEDline SEDline is monitored during the simultaneous period with the conventional EEG. Data retrieved from the SEDline are blindly interpreted by 3 investigators to determine the presence of seizure activity.

The presence of seizure activity in SEDline is determined by the definition
1. Electrographic seizure: rhythmic discharge or spike and wave pattern with definite evolution in frequency, location, or morphology lasting several seconds.
2. Spike: Transient, clearly distinguishable from background activity, with pointed peak at conventional paper speeds and a duration of 20 to less than 70 ms
4. Anti-epileptic drug The use of anti-epileptic drugs is guided by the results of conventional EEG or the presence of clinically seizure-like movement
5. Gold standard The presence of Seizure identified in conventional EEG.
6. Primary outcome The diagnostic performance of SEDline to detect seizure will be tested: Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and area under receiver operating characteristics curve (AUC).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Frontal 4 channel EEG

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Frontal 4 channel EEG

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SEDline, Masimo corporation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No