Clinical Trial

Cerebral Near Infrared Spectroscopy in Out-of-Hospital Cardiac Arrest and Neurological Prognosis

Study acronym: NISOHCA
Not Yet Recruiting
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Summary
Out-of-hospital cardiac arrest (OHCA) prognosis remains poor : 7% of patients surviving without neurological impairment. 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 .
Trial Details
NCT Number NCT06972329
Lead Sponsor Central Hospital, Nancy, France
Conditions Out-of-hospital Cardiac Arrest (OHCA)
Enrollment 542 participants
Start Date 2025-11
Primary Completion 2028-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2025-05-15