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

NCT06972329 | Not Yet Recruiting

• 2 other identifiers: 2022PI1262025-A00903-46
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 6

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 .

Conditions

Out-of-hospital Cardiac Arrest (OHCA)

Keywords

Out-of-hospital cardiac arrest; Cerebral Near infrared spectroscopy (NIRSc)

Outcome Measures

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.

  Day 90

Secondary Outcomes (7)

• Cerebral Performance Category (CPC)

  Day 90

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

  Day 90

• Return of Spontaneous Circulation

  1 hour

• The cumulative dose of adrenaline.

  During out-of-hospital cardiopulmonary resuscitation.

• Resuscitation duration.

  During out-of-hospital cardiopulmonary resuscitation.

Study Arms (1)

Cerebral Near infrared spectroscopy (NIRSc) group

EXPERIMENTAL

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).

Interventions

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).

Cerebral Near infrared spectroscopy (NIRSc) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Non-traumatic out-of-hospital cardiac arrest witnessed and managed by the mobile emergency unit (SMUR).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (6)

CH Colmar- Urgences - SAMU-SMUR

Colmar, 68000, France

Location

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

Metz, 5700, France

Location

CHRU NANCY - urgences SAMUR SMUR- Central hospital

Nancy, 54000, France

Location

CHU Reims - ugences - SAMU-SMUR

Reims, 51100, France

Location

Hôpitaux universitaire de Strasbourg - Urgences - SAMU-SMUR

Strasbourg, 67200, France

Location

CHR Troyes- Urgences - SAMU-SMUR

Troyes, 10000, France

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Nicolas GIRERD, MD-PhD

  CHRU de NANCY

  STUDY CHAIR

Central Study Contacts

Deborah JAEGER, MD

CONTACT

+33 (0) 3 83 85 85 85; D.JAEGER@chru-nancy.fr

Tahar CHOUIHED, MD PHD

CONTACT

+33 (0) 3 83 85 85 85; T.CHOUIHEDMAHJOUB@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: Out-of-hospital cardiac arrest (OHCA) study cohort with Cerebral Near infrared spectroscopy (NIRSc).

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

FR (6)