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

May 12, 2025 updated by: JAEGER Deborah, Central Hospital, Nancy, France

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

542

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Colmar, France, 68000
        • CH Colmar- Urgences - SAMU-SMUR
        • Contact:
        • Principal Investigator:
          • Yannick GOTTWALLES, MD
      • Metz, France, 5700
        • CHR Metz-Thionville - Mercy hospital -Urgences - SAMU-SMUR
        • Contact:
        • Principal Investigator:
          • Philippe Alarcon, MD
      • Nancy, France, 54000
        • CHRU NANCY - urgences SAMUR SMUR- Central hospital
        • Contact:
        • Principal Investigator:
          • Deborah JAEGER, MD
      • Reims, France, 51100
        • CHU Reims - ugences - SAMU-SMUR
        • Contact:
        • Principal Investigator:
          • Séphane GENNAI, MD
      • Strasbourg, France, 67200
        • Hôpitaux universitaire de Strasbourg - Urgences - SAMU-SMUR
        • Contact:
        • Principal Investigator:
          • Anne WEISS, MD
      • Troyes, France, 10000
        • CHR Troyes- Urgences - SAMU-SMUR
        • Contact:
        • Principal Investigator:
          • Alain HUGEROT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cerebral Near infrared spectroscopy (NIRSc) group
The use of cerebral Near infrared spectroscopy to predict the neurological prognosis of patients treated for out-of-hospital cardiac arrest.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 90
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
Day 90
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).
1 hour
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)
During out-of-hospital cardiopulmonary resuscitation.
Resuscitation duration.
Time Frame: During out-of-hospital cardiopulmonary resuscitation.
Evaluate the association between the average NIRSc and the duration of resuscitation (minutes).
During out-of-hospital cardiopulmonary resuscitation.
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)
During out-of-hospital cardiopulmonary resuscitation.
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)
During out-of-hospital cardiopulmonary resuscitation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Chair: Nicolas GIRERD, MD-PhD, CHRU de NANCY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

May 12, 2025

First Posted (Actual)

May 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI126
  • 2025-A00903-46 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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