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

NCT ID: NCT06972329

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

542 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-02-29

Brief Summary

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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 .

Detailed Description

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Conditions

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Out-of-hospital Cardiac Arrest (OHCA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Out-of-hospital cardiac arrest (OHCA) study cohort with Cerebral Near infrared spectroscopy (NIRSc).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cerebral Near infrared spectroscopy (NIRSc).

Intervention Type OTHER

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

Interventions

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Cerebral Near infrared spectroscopy (NIRSc).

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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JAEGER Deborah

Coordinating Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas GIRERD, MD-PhD

Role: STUDY_CHAIR

CHRU de NANCY

Locations

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CH Colmar- Urgences - SAMU-SMUR

Colmar, , France

Site Status

CHR Metz-Thionville - Mercy hospital -Urgences - SAMU-SMUR

Metz, , France

Site Status

CHRU NANCY - urgences SAMUR SMUR- Central hospital

Nancy, , France

Site Status

CHU Reims - ugences - SAMU-SMUR

Reims, , France

Site Status

Hôpitaux universitaire de Strasbourg - Urgences - SAMU-SMUR

Strasbourg, , France

Site Status

CHR Troyes- Urgences - SAMU-SMUR

Troyes, , France

Site Status

Countries

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France

Central Contacts

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Deborah JAEGER, MD

Role: CONTACT

+33 (0) 3 83 85 85 85

Tahar CHOUIHED, MD PHD

Role: CONTACT

+33 (0) 3 83 85 85 85

Facility Contacts

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Yannick GOTTWALLES, MD

Role: primary

+33 (0) 3 89 12 40 00

Philippe Alarcon, MD

Role: primary

+33 (0) 3 87 55 31 31

Deborah JAEGER, MD

Role: primary

+33 (0)3 83 85 85 85

Stéphane GENNAI, MD

Role: primary

+33 (0)3 26 78 78 78

Anne Weiss, MD

Role: primary

+33 (0)3 88 11 67 68

Alain HUGEROT, MD

Role: primary

+33 (3) 25 49 49 49

Other Identifiers

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2025-A00903-46

Identifier Type: OTHER

Identifier Source: secondary_id

2022PI126

Identifier Type: -

Identifier Source: org_study_id

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