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Completed

NCT Number: NCT02684955

Non-invasive Neurological Evaluation During CPR

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 .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SAMU 74, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cerebral spectroscopy

Device

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.

Other names: near-infrared spectroscopy - NIRS

Pupillometry

Device

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

Primary outcomes

  1. Prognostic value of rSO2, pupillometry, bystander CPR and initial cardiac rhythm alone or in association for survival at hospital admission

    Time frame: Through out-of-hospital care, an average of 2 hours

    rSO2, pupillometry, bystander CPR

Secondary outcomes

  1. prognostic value of capnography alone or in association with primary outcomes parameters for survival at hospital admission

    Time frame: Through out-of-hospital care, an average of 2 hours

    EtCO2

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: Neuro-E-CPR

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 18, 2016
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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