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

Central Hospital, Nancy, France

Status: Not yet enrolling

Conditions: Out-of-hospital Cardiac Arrest (OHCA)

Treatments: Other: Cerebral Near infrared spectroscopy (NIRSc).

Study type: Interventional

Funder types: Other

Identifiers

NCT06972329

2022PI126

2025-A00903-46 (Other Identifier)

Details and patient eligibility

About

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 .

Enrollment: 542 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Non-traumatic out-of-hospital cardiac arrest witnessed and managed by the mobile emergency unit (SMUR).

Exclusion criteria

• Scalp/cranial or facial injury preventing the placement of electrodes for NIRS measurement.
• Spontaneous cardiac activity upon the arrival of the SMUR.
• Decision by the SMUR physician not to initiate specialized resuscitation.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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542 participants in 1 patient group

Cerebral Near infrared spectroscopy (NIRSc) group

Experimental group

Description:

The use of cerebral Near infrared spectroscopy to predict the neurological prognosis of patients treated for out-of-hospital cardiac arrest.

Treatment:

Other: Cerebral Near infrared spectroscopy (NIRSc).