NCT04746820Befejeződött
Functional Near-infrared Spectroscopy in Unconscious Patients
Prognostic Value of Functional Near-infrared Spectroscopy in Unconscious Neurocritical Care Patients- a Prospective Pilot Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 19.
Rövid összefoglaló (regiszter, angolul)
The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients. In a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG). The primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation. fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. To compare fNIRS with evoked potentials there are two test phases: 1. The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP 2. The cerebral response to an auditory stimulus is measured by fNIRS and AEP To avoid biases the following has to be considered: * The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously. * If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 38 (tényleges)
- Első benyújtás
- 2020. nov. 12.
- Kezdés
- 2020. jan. 15.
- Elsődleges befejezés
- 2026. okt. 14.
- Fő szponzor
- Emanuela Keller
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT04746820
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 38
- 2020. jan. 15. és az elsődleges befejezés (2026. okt. 14.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Previous auditory complaints or any ear diseases
- Any history of previous cerebral or brainstem disease
- Concomitant instable critical illness (e.g. sepsis, multi-organ failure, hemodynamic or respiratory instability)
- Previous auditory complaints or any ear diseases
- Any history of previous cerebral or brainstem disease
Életkor
- Patients age < 18 years
- Subjects age < 18 years
Egyéb
- Positive pregnancy test for any female of childbearing potential or breast feeding female
- No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.)
- Acute status epilepticus
- Clinical recovery (GCS ≥ 9) or death before enrolment of the study
- Positive pregnancy test for any female of childbearing potential or breast feeding female
- No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.)
Kiket keres a vizsgálat
- Patients of either sex with severe hemorrhagic, ischemic stroke or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation treated at the Institute of Intensive Care Medicine, University Hospital Zurich
- Unconsciousness (GCS < 9) or sedated to the severity of the disease (for the subgroup of patients included in the fNIRS-EEG measurement unconscious patients are defined as not responding to verbal stimuli. The motor response to pain should be one of the following: no response to pain / extensor response / flexor response / localize to pain)
- Age ≥ 18 years
- Signed informed consent obtained from legal representative
- Measurement logistically and technical possible within the first 7 days after admission
- Subjects of either sex
- Conscious (GCS = 15)
- Age ≥ 18 years
- Signed informed consent
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Hospital Zurich | Zurich | Svájc | Ismeretlen állapot |
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