Acute Ischemic Stroke Patients
Conditions
Keywords
Stroke, Ischemic Stroke, Acute Ischemic Stroke, Cerebral Oxygen Saturation(rSO2)
Brief summary
The clinical trial is for acute ischemic stroke patients measuring cerebral oxygen saturation (rSO2) values using pulse oximeter of near-infrared spectroscopy in the frontal lesion area and normal area of brain. The purpose of the clinical trial is to compare differences in cerebral oxygen saturation values, and the efficacy and safety are evaluated through additional exploratory clinical trials.
Interventions
DEVICEPulse oximeter, NIRSITX
It is a device that non-invasively continuously monitors blood oxygen saturation (rSO2) in localized areas of the brain. This device is attached to patients with symptoms suspected of stroke or diagnosed with stroke to continuously monitor the level of oxygen supply to the brain.
Sponsors
OBELAB, Inc.
Helptrial Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over age 19 * Patients diagnosed with acute ischemic stroke within 7 days of symptom onset * Patient's condition confirmed to have an acute ischemic stroke and also brain blood vessels condition confirmed through brain imaging such as Brain CT/CTA/CT perfusion and Brain MRI/MRA * Patients voluntarily agree to participate and scheduled to participate in this clinical trial * Patients willing to comply with the clinical trial protocol
Exclusion criteria
* Patients without brain imaging result * Patients diagnosed with jaundice (hyperbilirubinemia) with abnormal skin color - Patients who find it difficult to wear medical devices for clinical trial on their foreheads * Patients who has skull fractures of external shape not maintained normal * Patients who does not agree to participate in this clinical trial * Patients who are currently participating in another clinical trial or have participated in another clinical trial within 30 days of the screening date * Patients who is determined from investigator that participating is inappropriate because it may affect the results of the clinical trial or ethically
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of rSO2 values obtained from NIRSITX, a medical device for clinical trials, between the frontal lobe on the side with brain lesions and the frontal lobe on the contralateral side. | Baseline and follow-up (24 hours later) | The number of study subjects, mean, standard deviation, median, minimum, and maximum are presented as descriptive statistics for the difference and rate of change in rSO2 values obtained from medical equipment for clinical trials between the frontal lobe on the side with the brain lesion and the frontal lobe on the contralateral side. The statistical significance of the change in rSO2 values between two areas is tested using the t-test or Wilcoxon test. |
Countries
South Korea
Outcome results
None listed