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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00903-46 | Other Identifier | ANSM |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral Near infrared spectroscopy (NIRSc) group | Experimental | The use of cerebral Near infrared spectroscopy to predict the neurological prognosis of patients treated for out-of-hospital cardiac arrest. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral Near infrared spectroscopy (NIRSc). | Other | Continuous cerebral near-infrared spectroscopy (NIRSc) during resuscitation in a patient treated for out-of-hospital cardiac arrest (OHCA). |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Performance Category (CPC) | Specificity of predicting a 90-D survival with a good neurological outcome with a mean c-NIRS > 40% during Cardiopulmonary Resuscitation (CPR). Cerebral Performance Category (CPC) of 1 to 5. CPC 1: Complete recovery without neurological impairment or conscious with minor impairment. CPC 5: Deceased or brain dead. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Performance Category (CPC) | Determine the probability of observing a poor neurological prognosis at 90 days if the average cerebral NIRS (NIRSc) is below 40% during resuscitation. Determine the probability of observing a good neurological prognosis at 90 days if the average cerebral NIRS (NIRSc) is greater than or equal to 40% during resuscitation. Identify the most appropriate NIRSc threshold to predict a good neurological prognosis at 90 days. Build a multi-marker model for neurological prognosis including NIRSc. Cerebral Performance Category (CPC) of 1 to 5. CPC 1: Complete recovery without neurological impairment or conscious with minor impairment. CPC 5: Deceased or brain dead. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah JAEGER, MD | Contact | +33 (0) 3 83 85 85 85 | D.JAEGER@chru-nancy.fr | |
| Tahar CHOUIHED, MD PHD | Contact | +33 (0) 3 83 85 85 85 | T.CHOUIHEDMAHJOUB@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas GIRERD, MD-PhD | CHRU de NANCY | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Colmar- Urgences - SAMU-SMUR | Colmar | 68000 | France |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Out-of-hospital cardiac arrest (OHCA) study cohort with Cerebral Near infrared spectroscopy (NIRSc).
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| Day 90 |
| Cerebral Performance Category (CPC) after Return of Spontaneous Circulation(ROSC) | Assessment of c-NIRS after Return of Spontaneous Circulation(ROSC) for patients with a good neurological outcome at 90-D. Cerebral Performance Category (CPC) of 1 to 5. CPC 1: Complete recovery without neurological impairment or conscious with minor impairment. CPC 5: Deceased or brain dead | Day 90 |
| Return of Spontaneous Circulation | Evaluate the association between the average Cerebral Near infrared spectroscopy (NIRSc) and the occurrence of ROSC (Return of Spontaneous Circulation). | 1 hour |
| The cumulative dose of adrenaline. | Evaluate the association between the average NIRSc and the cumulative dose of adrenaline (mg/mL) | During out-of-hospital cardiopulmonary resuscitation. |
| Resuscitation duration. | Evaluate the association between the average NIRSc and the duration of resuscitation (minutes). | During out-of-hospital cardiopulmonary resuscitation. |
| No-flow duration | Evaluate the association between the average NIRSc and the duration of no flow (minutes) | During out-of-hospital cardiopulmonary resuscitation. |
| Initial rhythm (Shockable or non-Shockable) | Evaluate the association between the average NIRSc and the inital rhythm (Shockable or non-Shockable) | During out-of-hospital cardiopulmonary resuscitation. |
| CHR Metz-Thionville - Mercy hospital -Urgences - SAMU-SMUR | Metz | 5700 | France |
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| CHRU NANCY - urgences SAMUR SMUR- Central hospital | Nancy | 54000 | France |
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| CHU Reims - ugences - SAMU-SMUR | Reims | 51100 | France |
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| Hôpitaux universitaire de Strasbourg - Urgences - SAMU-SMUR | Strasbourg | 67200 | France |
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| CHR Troyes- Urgences - SAMU-SMUR | Troyes | 10000 | France |
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