Out-of-hospital Cardiac Arrest (OHCA)NISOHCANCT06972329
Cerebral Near Infrared Spectroscopy in Out-of-Hospital Cardiac Arrest and Neurological Prognosis
A study testing Cerebral Near infrared spectroscopy (NIRSc). in people with Out-of-hospital Cardiac Arrest (OHCA), run by Central Hospital, Nancy, France at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest (OHCA)
- What is being tested?
- Cerebral Near infrared spectroscopy (NIRSc).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 6 sitesFrance
- Study dates
- Nov 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Non-traumatic out-of-hospital cardiac arrest witnessed and managed by the mobile emergency unit (SMUR).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
CH Colmar- Urgences - SAMU-SMUR
Colmar, 68000
Yannick GOTTWALLES, MD, +33 (0) 3 89 12 40 00, yannick.gottwalles@ch-colmar.fr
Yannick GOTTWALLES, MD
CHR Metz-Thionville - Mercy hospital -Urgences - SAMU-SMUR
Metz, 5700
Philippe Alarcon, MD, +33 (0) 3 87 55 31 31, philippe.alarcon@chr-metz-thionville.fr
Philippe Alarcon, MD
CHRU NANCY - urgences SAMUR SMUR- Central hospital
Nancy, 54000
Deborah JAEGER, MD, +33 (0)3 83 85 85 85, D.JAEGER@chru-nancy.fr
Deborah JAEGER, MD
CHU Reims - ugences - SAMU-SMUR
Reims, 51100
Stéphane GENNAI, MD, +33 (0)3 26 78 78 78, sgennai@chu-reims.fr
Séphane GENNAI, MD
Hôpitaux universitaire de Strasbourg - Urgences - SAMU-SMUR
Strasbourg, 67200
Anne Weiss, MD, +33 (0)3 88 11 67 68, anne.weiss@chru-strasbourg.fr
Anne WEISS, MD
CHR Troyes- Urgences - SAMU-SMUR
Troyes, 10000
Alain HUGEROT, MD, +33 (3) 25 49 49 49, alain.hugerot@ch-troyes.fr
Alain HUGEROT, MD
About this study
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.
Read more
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)
- Being tested
- Cerebral Near infrared spectroscopy (NIRSc).
- Keywords
- Out-of-hospital cardiac arrest, Cerebral Near infrared spectroscopy (NIRSc)
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cerebral Near infrared spectroscopy (NIRSc). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90
Secondary outcomes (7)
Cerebral Performance Category (CPC)
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.
Measured: Day 90
Cerebral Performance Category (CPC) after Return of Spontaneous Circulation(ROSC)
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
Measured: Day 90
Return of Spontaneous Circulation
Evaluate the association between the average Cerebral Near infrared spectroscopy (NIRSc) and the occurrence of ROSC (Return of Spontaneous Circulation).
Measured: 1 hour
The cumulative dose of adrenaline.
Evaluate the association between the average NIRSc and the cumulative dose of adrenaline (mg/mL)
Measured: During out-of-hospital cardiopulmonary resuscitation.
Resuscitation duration.
Evaluate the association between the average NIRSc and the duration of resuscitation (minutes).
Measured: During out-of-hospital cardiopulmonary resuscitation.
No-flow duration
Evaluate the association between the average NIRSc and the duration of no flow (minutes)
Measured: During out-of-hospital cardiopulmonary resuscitation.
Initial rhythm (Shockable or non-Shockable)
Evaluate the association between the average NIRSc and the inital rhythm (Shockable or non-Shockable)
Measured: During out-of-hospital cardiopulmonary resuscitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac Arrest (OHCA)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Out-of-hospital cardiac arrest (OHCA) study cohort with Cerebral Near infrared spectroscopy (NIRSc).
- Masking
- None (open label)
- Enrolment
- 542 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAEGER Deborah, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, MD-PhD, Study chair, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972329
- Sponsor's protocol ID
- 2022PI126
- Other IDs
- 2025-A00903-46
- Acronym
- NISOHCA
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Near Infrared Spectroscopy in Out-of-Hospital Cardiac Arrest and Neurological Prognosis
- ClinicalTrials.gov ID
- NCT06972329
- Acronym / sponsor ID
- NISOHCA / 2022PI126
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Keywords
- Out-of-hospital cardiac arrest, Cerebral Near infrared spectroscopy (NIRSc)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 542 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Out-of-hospital cardiac arrest (OHCA) study cohort with Cerebral Near infrared spectroscopy (NIRSc).
| Arm | Type | Receives |
|---|---|---|
| Cerebral Near infrared spectroscopy (NIRSc) group | Experimental | Other: Cerebral Near infrared spectroscopy (NIRSc).The use of cerebral Near infrared spectroscopy to predict the neurological prognosis of patients treated for out-of-hospital cardiac arrest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years.
- Non-traumatic out-of-hospital cardiac arrest witnessed and managed by the mobile emergency unit (SMUR).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral Near infrared spectroscopy (NIRSc).Continuous cerebral near-infrared spectroscopy (NIRSc) during resuscitation in a patient treated for out-of-hospital cardiac arrest (OHCA). | Other | Cerebral Near infrared spectroscopy (NIRSc) group |
Primary outcome
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.
7 secondary outcomes
Cerebral Performance Category (CPC)
Time frame: Day 90
Cerebral Performance Category (CPC) after Return of Spontaneous Circulation(ROSC)
Time frame: Day 90
Return of Spontaneous Circulation
Time frame: 1 hour
The cumulative dose of adrenaline.
Time frame: During out-of-hospital cardiopulmonary resuscitation.
Resuscitation duration.
Time frame: During out-of-hospital cardiopulmonary resuscitation.
No-flow duration
Time frame: During out-of-hospital cardiopulmonary resuscitation.
Initial rhythm (Shockable or non-Shockable)
Time frame: During out-of-hospital cardiopulmonary resuscitation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas GIRERD, MD-PhD study chair
CHRU de NANCY
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral Near infrared spectroscopy (NIRSc). in people with Out-of-hospital Cardiac Arrest (OHCA), run by Central Hospital, Nancy, France at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah JAEGER, MD (+33 (0) 3 83 85 85 85, D.JAEGER@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Performance Category (CPC) (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.