Cerebral Near Infrared Spectroscopy in Out-of-Hospital Cardiac Arrest and Neurological Prognosis
NCT ID: NCT06972329
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
542 participants
INTERVENTIONAL
2025-11-30
2028-02-29
Brief Summary
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65% of patients dying after hospital admission were neurologically impaired. When treating a patient with CA, neurological outcome remains extremely difficult to predict, especially in the pre-hospital setting. Practitioners have very little objective information to help them with neuropronostication.
Although an EtCO2 level of \< 10 mmHg is associated with a poor neurological prognosis, European recommendations point out that this data alone is not currently sufficient to predict a patient's prognosis or to make a decision to stop resuscitation. Current recommendations do not suggest any other objective parameter during resuscitation for neuropronostication of patients with out-of-hospital cardiac arrest.
Cerebral tissue oxygen saturation (rSO2) is measured using the near infrared spectrometry (NIRS) technique. Cerebral NIRS (cNIRS) enables non-invasive measurement of changes in cerebral oximetry during the management of a cardiac arrest (CA).
Various clinical studies conducted over the last ten years have demonstrated that there is a probable link between cNIRS levels during resuscitation and return of spontaneous circulation (ROSC), but a clear threshold value has not been defined.
The aim of the NISOHCA study is to confirm that a 40% threshold of cNIRS in the pre-hospital setting for OHCA can specifically predict survival with good neurological outcome at D90 .
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Cerebral Near infrared spectroscopy (NIRSc) group
The use of cerebral Near infrared spectroscopy to predict the neurological prognosis of patients treated for out-of-hospital cardiac arrest.
Cerebral Near infrared spectroscopy (NIRSc).
Continuous cerebral near-infrared spectroscopy (NIRSc) during resuscitation in a patient treated for out-of-hospital cardiac arrest (OHCA).
Interventions
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Cerebral Near infrared spectroscopy (NIRSc).
Continuous cerebral near-infrared spectroscopy (NIRSc) during resuscitation in a patient treated for out-of-hospital cardiac arrest (OHCA).
Eligibility Criteria
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Inclusion Criteria
* Non-traumatic out-of-hospital cardiac arrest witnessed and managed by the mobile emergency unit (SMUR).
Exclusion Criteria
* Spontaneous cardiac activity upon the arrival of the SMUR.
* Decision by the SMUR physician not to initiate specialized resuscitation.
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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JAEGER Deborah
Coordinating Investigator
Principal Investigators
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Nicolas GIRERD, MD-PhD
Role: STUDY_CHAIR
CHRU de NANCY
Locations
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CH Colmar- Urgences - SAMU-SMUR
Colmar, , France
CHR Metz-Thionville - Mercy hospital -Urgences - SAMU-SMUR
Metz, , France
CHRU NANCY - urgences SAMUR SMUR- Central hospital
Nancy, , France
CHU Reims - ugences - SAMU-SMUR
Reims, , France
Hôpitaux universitaire de Strasbourg - Urgences - SAMU-SMUR
Strasbourg, , France
CHR Troyes- Urgences - SAMU-SMUR
Troyes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A00903-46
Identifier Type: OTHER
Identifier Source: secondary_id
2022PI126
Identifier Type: -
Identifier Source: org_study_id
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