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NOT YET RECRUITING
NCT06972329
NA

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

Sponsor: Central Hospital, Nancy, France

View on ClinicalTrials.gov

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 .

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

542

Start Date

2025-11

Completion Date

2028-02

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

OTHER

Cerebral Near infrared spectroscopy (NIRSc).

Continuous cerebral near-infrared spectroscopy (NIRSc) during resuscitation in a patient treated for out-of-hospital cardiac arrest (OHCA).

Locations (6)

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