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Non-invasive Neurological Evaluation During CPR

Non-invasive Neurological Evaluation During Cardiopulmonary Resuscitation for Out of Hospital Cardiac Arrest Patients Neuro-E-CPR Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02684955
Acronym
Neuro-E-CPR
Enrollment
112
Registered
2016-02-18
Start date
2016-02-09
Completion date
2019-08-22
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

cardiac arrest, near-infrared spectroscopy, automated infrared pupillometry, prognostication

Brief summary

Cardiac arrest remains a leading cause of death, currently affecting \>250,000 Europeans outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between 15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest, the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with trained resuscitation teams. However, only 5-10% of patients will survive with good neurological status. A good quality CPR, a short time before initiation of the resuscitation and a short delay before the first defibrillation have been associated with improved neurological outcome. Unfortunately it is currently impossible to obtain reliable information on the quality of the perfusion and oxygenation of organs during CPR. The current monitoring during CPR is limited to heart rhythm analysis, pulse rate evaluation and end tidal CO2 (EtCO2). The last one is the only parameter which have been linked with probability of ROSC and its value gives no indication of the long-term prognosis nor the neurological status. Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation. This technique has been recently used in cardiac arrest showing a possible association between rSO2 measured during CPR and the occurrence of ROSC or survival. The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome in the hospital for patient successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility study has shown that its use was also possible during CPR in the pre-hospital setting. The investigators aim to study a composite prognostic factor combining quantitative rSO2 and automated pupillometry measured during CPR. The investigators hypothesized that the rate of survival with good neurologic outcome at 30 days will be lower in patients with rSO2 \<30% for more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR .

Interventions

DEVICECerebral spectroscopy

Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation.

DEVICEPupillometry

The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adults with nontraumatic, out-of-hospital cardiac arrest

Exclusion criteria

* Traumatic cardiac arrest * Patients who had achieved ROSC before inclusion patients with a do-not-attempt resuscitation order * Patients \< 18 years old * Subjects known to be pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Prognostic value of rSO2, pupillometry, bystander CPR and initial cardiac rhythm alone or in association for survival at hospital admissionThrough out-of-hospital care, an average of 2 hoursrSO2, pupillometry, bystander CPR

Secondary

MeasureTime frameDescription
prognostic value of capnography alone or in association with primary outcomes parameters for survival at hospital admissionThrough out-of-hospital care, an average of 2 hoursEtCO2

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026