Clinical trial NCT06972329: Cerebral Near Infrared Spectroscopy in Out-of-Hospital Cardiac Arrest and Neurological Prognosis
Official title: Cerebral Near Infrared Spectroscopy in Out-of-Hospital Cardiac Arrest and Neurological Prognosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Out-of-hospital Cardiac Arrest (OHCA)
Keywords: Out-of-hospital cardiac arrest
Cerebral Near infrared spectroscopy (NIRSc)
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Out-of-hospital cardiac arrest (OHCA) study cohort with Cerebral Near infrared spectroscopy (NIRSc).
Primary purpose: BASIC_SCIENCE

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Cerebral Performance Category (CPC)
timeFrame: Day 90
Secondary outcomes:
measure: Cerebral Performance Category (CPC)
timeFrame: Day 90
measure: Cerebral Performance Category (CPC) after Return of Spontaneous Circulation(ROSC)
timeFrame: Day 90
measure: Return of Spontaneous Circulation
timeFrame: 1 hour
measure: The cumulative dose of adrenaline.
timeFrame: During out-of-hospital cardiopulmonary resuscitation.
measure: Resuscitation duration.
timeFrame: During out-of-hospital cardiopulmonary resuscitation.
measure: No-flow duration
timeFrame: During out-of-hospital cardiopulmonary resuscitation.
measure: Initial rhythm (Shockable or non-Shockable)
timeFrame: During out-of-hospital cardiopulmonary resuscitation.
Other outcomes:
Locations:
city: Colmar
country: France
facility: CH Colmar- Urgences - SAMU-SMUR
city: Metz
country: France
facility: CHR Metz-Thionville - Mercy hospital -Urgences - SAMU-SMUR
city: Nancy
country: France
facility: CHRU NANCY - urgences SAMUR SMUR- Central hospital
city: Reims
country: France
facility: CHU Reims - ugences - SAMU-SMUR
city: Strasbourg
country: France
facility: Hôpitaux universitaire de Strasbourg - Urgences - SAMU-SMUR
city: Troyes
country: France
facility: CHR Troyes- Urgences - SAMU-SMUR
Study officials:
affiliation: CHRU de NANCY
name: Nicolas GIRERD, MD-PhD
role: STUDY_CHAIR
References: