Non-invasive Neurological Evaluation During CPR (Neuro-E-CPR)

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

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 .

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: Cerebral spectroscopy; Device: Pupillometry

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

• Study Contact: Name: Guillaume Debaty, MD, PhD; Phone Number: 0033476634202; Email: gdebaty@chu-grenoble.fr
• Study Contact Backup: Name: Cyrielle Clapé, PhD; Phone Number: 0033476634202; Email: cclape@chu-grenoble.fr

Study Locations

• France
  • Annecy, France
    • SAMU 74
  • Grenoble, France, 38043
    • SAMU 38

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Out of Hospital cardiac arrest patient

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cerebral spectroscopy + pupillometry; During CPR, rSO2 will be monitored continuously as well as quantitative measurements of the pupillary light reaction every 5 minutes.

Device: Cerebral 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.; Other Names: near-infrared spectroscopy - NIRS; Device: Pupillometry; The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival status at hospital admission	Alive patients at hospital admission	hospital admission - Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurologic outcome, based on Cerebral Performance Category (CPC) score: CPC 1 or 2	As measured by using the Cerebral Performance Category (CPC) score: CPC 1 (good cerebral performance) or CPC 2 (moderate cerebral disability)	Day 30
Survival status at hospital discharge	Alive patients at hospital discharge	up to 30 days if still hospitalized
Survival status at Day 30	Vital status at 30 days	Day 30
Neurologic outcome, based on CPC score at hospital discharge	As measured by using the Cerebral Performance Category (CPC) score: CPC 1 (good cerebral performance), CPC 2 (moderate cerebral disability), CPC 3 (severe cerebral disablity), CPC 4 (coma or vegetative state) or CPC 5 (brain death)	up to 30 days if still hospitalized

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Dominique Savary, MD, Annecy Hospital

Publications and helpful links

General Publications

• Levine RL, Wayne MA, Miller CC. End-tidal carbon dioxide and outcome of out-of-hospital cardiac arrest. N Engl J Med. 1997 Jul 31;337(5):301-6. doi: 10.1056/NEJM199707313370503.
• Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.
• Ito N, Nishiyama K, Callaway CW, Orita T, Hayashida K, Arimoto H, Abe M, Endo T, Murai A, Ishikura K, Yamada N, Mizobuchi M, Anan H, Okuchi K, Yasuda H, Mochizuki T, Tsujimura Y, Nakayama T, Hatanaka T, Nagao K; J-POP Registry Investigators. Noninvasive regional cerebral oxygen saturation for neurological prognostication of patients with out-of-hospital cardiac arrest: a prospective multicenter observational study. Resuscitation. 2014 Jun;85(6):778-84. doi: 10.1016/j.resuscitation.2014.02.012. Epub 2014 Mar 5.
• Singer AJ, Ahn A, Inigo-Santiago LA, Thode HC Jr, Henry MC, Parnia S. Cerebral oximetry levels during CPR are associated with return of spontaneous circulation following cardiac arrest: an observational study. Emerg Med J. 2015 May;32(5):353-6. doi: 10.1136/emermed-2013-203467. Epub 2014 Mar 24.
• Schewe JC, Thudium MO, Kappler J, Steinhagen F, Eichhorn L, Erdfelder F, Heister U, Ellerkmann R. Monitoring of cerebral oxygen saturation during resuscitation in out-of-hospital cardiac arrest: a feasibility study in a physician staffed emergency medical system. Scand J Trauma Resusc Emerg Med. 2014 Oct 5;22:58. doi: 10.1186/s13049-014-0058-y.
• Suys T, Bouzat P, Marques-Vidal P, Sala N, Payen JF, Rossetti AO, Oddo M. Automated quantitative pupillometry for the prognostication of coma after cardiac arrest. Neurocrit Care. 2014 Oct;21(2):300-8. doi: 10.1007/s12028-014-9981-z.
• Behrends M, Niemann CU, Larson MD. Infrared pupillometry to detect the light reflex during cardiopulmonary resuscitation: a case series. Resuscitation. 2012 Oct;83(10):1223-8. doi: 10.1016/j.resuscitation.2012.05.013. Epub 2012 May 30.

Study record dates

Study Major Dates

• Study Start: February 2, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cardiac arrest; near-infrared spectroscopy; prognostication; automated infrared pupillometry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: Neuro-E-CPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED