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

Overview

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 .

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).

Primary outcome measures

• Cerebral Performance Category (CPC) [Time frame: Day 90]

Secondary outcome measures (7)

• Cerebral Performance Category (CPC) [Time frame: Day 90]
• Cerebral Performance Category (CPC) after Return of Spontaneous Circulation(ROSC) [Time frame: Day 90]
• Return of Spontaneous Circulation [Time frame: 1 hour]
• The cumulative dose of adrenaline. [Time frame: During out-of-hospital cardiopulmonary resuscitation.]
• Resuscitation duration. [Time frame: During out-of-hospital cardiopulmonary resuscitation.]
• No-flow duration [Time frame: During out-of-hospital cardiopulmonary resuscitation.]
• Initial rhythm (Shockable or non-Shockable) [Time frame: During out-of-hospital cardiopulmonary resuscitation.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

France · 6 centers

• CH Colmar- Urgences - SAMU-SMUR — Colmar
• CHR Metz-Thionville - Mercy hospital -Urgences - SAMU-SMUR — Metz
• CHRU NANCY - urgences SAMUR SMUR- Central hospital — Nancy
• CHU Reims - ugences - SAMU-SMUR — Reims
• Hôpitaux universitaire de Strasbourg - Urgences - SAMU-SMUR — Strasbourg
• CHR Troyes- Urgences - SAMU-SMUR — Troyes

Identifiers

NCT: NCT06972329 · 2022PI126 · 2025-A00903-46

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗