Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746820
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2020-11-12
Brief Title:
Functional Near-infrared Spectroscopy in Unconscious Patients
Sponsor:
Emanuela Keller
Organization:
University of Zurich
Study Overview
Official Title:
Prognostic Value of Functional Near-infrared Spectroscopy in Unconscious Neurocritical Care Patients- a Prospective Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
fNIRS
Brief Summary:
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
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
Detailed Description:
Severe ischemic and hemorrhagic stroke as well cardiac arrest even after successful cardiopulmonary reanimation are great causes of morbidity and mortality in Europe and worldwide Although prevention and therapy strategies have been successfully improved during the past decades the global stroke burden - measured in disability adjusted life years DALY - is still great
Specifically the improvements of intensive care treatments and neurosurgical procedures have lowered mortality rates but simultaneously have increased survivors with severe disorder of consciousness DoC or persistent disabilities As a result an early prognosis in unconscious patients suffering from severe stroke in the intensive care unit ICU becomes more important for the clinician An early reliable prognosis enables the clinician to empower the surrogates of an unconscious patient to make choices consistent with his preferences It improves also overall patient management in the NICU and helps to identify an appropriate rehabilitation care Since clinical assessment of comatose Patients is limited other examinations are needed to enhance the reliability of a prognosis
Evoked potentials especially somatosensory and auditory evoked potentials SSEP and AEP are well established prognostic tools in unconscious ICU patients
The advantage of evoked potentials over clinical assessments such as the Glasgow coma score GCS or laboratory values are that they are not influenced by intensive care interventions and have a higher interrater reliability They are also resistant to metabolic changes or sedation
Electroencephalography EEG is another established prognostic tool in comatose patients However both evoked potential and EEG are highly vulnerable to artefacts and expensive due to high workforce requirements
Functional near-infrared spectroscopy fNIRS is a promising strictly non-invasive bedside examination It is based on the finding that infrared light is absorbed by oxygenated and deoxygenated haemoglobin Brain activation can be measured with fNIRS due to an increase of oxygenated haemoglobin and decrease of deoxygenated haemoglobin Different studies show that brain activation as a response to peripheral somatosensory and auditory stimulation as it is conducted in SSEP and AEP can be detected by fNIRS Recent studies investigated also the use of fNIRS in unconscious patients However it is unknown whether and how the brain activation measured by fNIRS due to sensory stimulation correlates to the measurements of evoked potentials in unconscious patients and if it has any prognostic value in unconscious patients
Therefore the investigator aims to compare fNIRS with SSEP and AEP in unconscious neuro-intensive care patients suffering from severe hemorrhagic or ischemic stroke and in a control group with healthy conscious subjects Hence making it a potential prognostic tool for unconscious ICU patients
Specifically the improvements of intensive care treatments and neurosurgical procedures have lowered mortality rates but simultaneously have increased survivors with severe disorder of consciousness DoC or persistent disabilities As a result an early prognosis in unconscious patients suffering from severe stroke in the intensive care unit ICU becomes more important for the clinician An early reliable prognosis enables the clinician to empower the surrogates of an unconscious patient to make choices consistent with his preferences It improves also overall patient management in the NICU and helps to identify an appropriate rehabilitation care Since clinical assessment of comatose Patients is limited other examinations are needed to enhance the reliability of a prognosis
Evoked potentials especially somatosensory and auditory evoked potentials SSEP and AEP are well established prognostic tools in unconscious ICU patients
The advantage of evoked potentials over clinical assessments such as the Glasgow coma score GCS or laboratory values are that they are not influenced by intensive care interventions and have a higher interrater reliability They are also resistant to metabolic changes or sedation
Electroencephalography EEG is another established prognostic tool in comatose patients However both evoked potential and EEG are highly vulnerable to artefacts and expensive due to high workforce requirements
Functional near-infrared spectroscopy fNIRS is a promising strictly non-invasive bedside examination It is based on the finding that infrared light is absorbed by oxygenated and deoxygenated haemoglobin Brain activation can be measured with fNIRS due to an increase of oxygenated haemoglobin and decrease of deoxygenated haemoglobin Different studies show that brain activation as a response to peripheral somatosensory and auditory stimulation as it is conducted in SSEP and AEP can be detected by fNIRS Recent studies investigated also the use of fNIRS in unconscious patients However it is unknown whether and how the brain activation measured by fNIRS due to sensory stimulation correlates to the measurements of evoked potentials in unconscious patients and if it has any prognostic value in unconscious patients
Therefore the investigator aims to compare fNIRS with SSEP and AEP in unconscious neuro-intensive care patients suffering from severe hemorrhagic or ischemic stroke and in a control group with healthy conscious subjects Hence making it a potential prognostic tool for unconscious ICU patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None