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NCT Number: NCT06972329

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

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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Key information

Conditions

Out-Of-Hospital Cardiac Arrest (OHCA) Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Colmar- Urgences - SAMU-SMUR, Colmar, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Cerebral Performance Category (CPC)

    Time frame: 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 outcomes

  1. Cerebral Performance Category (CPC)

    Time frame: 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.

  2. Cerebral Performance Category (CPC) after Return of Spontaneous Circulation(ROSC)

    Time frame: 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

  3. Return of Spontaneous Circulation

    Time frame: 1 hour

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

  4. The cumulative dose of adrenaline.

    Time frame: During out-of-hospital cardiopulmonary resuscitation.

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

  5. Resuscitation duration.

    Time frame: During out-of-hospital cardiopulmonary resuscitation.

    Evaluate the association between the average NIRSc and the duration of resuscitation (minutes).

  6. No-flow duration

    Time frame: During out-of-hospital cardiopulmonary resuscitation.

    Evaluate the association between the average NIRSc and the duration of no flow (minutes)

  7. Initial rhythm (Shockable or non-Shockable)

    Time frame: During out-of-hospital cardiopulmonary resuscitation.

    Evaluate the association between the average NIRSc and the inital rhythm (Shockable or non-Shockable)

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah JAEGER, MD

CONTACT

[email protected]

+33 (0) 3 83 85 85 85

Tahar CHOUIHED, MD PHD

CONTACT

[email protected]

+33 (0) 3 83 85 85 85

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: NISOHCA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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