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

ConditionOut-of-hospital Cardiac Arrest (OHCA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Cerebral Near infrared spectroscopy (NIRSc).

    Other intervention

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

Treatment groups

542 Participants
are divided into 1 treatment group
Group A: Cerebral Near infrared spectroscopy (NIRSc) groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 90

Secondary outcomes

1

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.

Time frame
Day 90
2

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

Time frame
Day 90
3

Return of Spontaneous Circulation

Evaluate the association between the average Cerebral Near infrared spectroscopy (NIRSc) and the occurrence of ROSC (Return of Spontaneous Circulation).

Time frame
1 hour
4

The cumulative dose of adrenaline.

Evaluate the association between the average NIRSc and the cumulative dose of adrenaline (mg/mL)

Time frame
During out-of-hospital cardiopulmonary resuscitation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Central Hospital, Nancy, France

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: