Out-of-hospital Cardiac Arrest (OHCA)
Conditions
Keywords
Out-of-hospital cardiac arrest, Cerebral Near infrared spectroscopy (NIRSc)
Brief 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 .
Interventions
OTHERCerebral Near infrared spectroscopy (NIRSc).
Continuous cerebral near-infrared spectroscopy (NIRSc) during resuscitation in a patient treated for out-of-hospital cardiac arrest (OHCA).
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Out-of-hospital cardiac arrest (OHCA) study cohort with Cerebral Near infrared spectroscopy (NIRSc).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Performance Category (CPC) | Day 90 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Performance Category (CPC) after Return of Spontaneous Circulation(ROSC) | Day 90 | 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 |
| Return of Spontaneous Circulation | 1 hour | Evaluate the association between the average Cerebral Near infrared spectroscopy (NIRSc) and the occurrence of ROSC (Return of Spontaneous Circulation). |
| The cumulative dose of adrenaline. | During out-of-hospital cardiopulmonary resuscitation. | Evaluate the association between the average NIRSc and the cumulative dose of adrenaline (mg/mL) |
| Cerebral Performance Category (CPC) | Day 90 | 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. |
| No-flow duration | During out-of-hospital cardiopulmonary resuscitation. | Evaluate the association between the average NIRSc and the duration of no flow (minutes) |
| Initial rhythm (Shockable or non-Shockable) | During out-of-hospital cardiopulmonary resuscitation. | Evaluate the association between the average NIRSc and the inital rhythm (Shockable or non-Shockable) |
| Resuscitation duration. | During out-of-hospital cardiopulmonary resuscitation. | Evaluate the association between the average NIRSc and the duration of resuscitation (minutes). |
Countries
France
Contacts
Primary ContactDeborah JAEGER, MD
Backup ContactTahar CHOUIHED, MD PHD
Outcome results
None listed