Non-invasive Neurological Evaluation During CPR

NCT02684955 | Completed DMC

• 1 other identifier: Neuro-E-CPR
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 2

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 .

Conditions

Cardiac Arrest

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  rSO2, pupillometry, bystander CPR

  Through out-of-hospital care, an average of 2 hours

Secondary Outcomes (1)

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

  Through out-of-hospital care, an average of 2 hours

Study Arms (1)

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; Device: Pupillometry

Interventions

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.

Also known as: near-infrared spectroscopy - NIRS

Cerebral spectroscopy + pupillometry

Pupillometry DEVICE

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

Cerebral spectroscopy + pupillometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Out of Hospital cardiac arrest patient

You may qualify if:

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

You may not qualify if:

• Traumatic cardiac arrest
• Patients \< 18 years old
• Subjects known to be pregnant or breastfeeding

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

SAMU 74

Annecy, France

Location

SAMU 38

Grenoble, 38043, France

Location

Related Publications (7)

• 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.

  PMID: 9233867 BACKGROUND

• 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.

  PMID: 24795284 BACKGROUND

• 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.

  PMID: 24606889 BACKGROUND

• 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.

  PMID: 24662518 BACKGROUND

• 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.

  PMID: 25286829 BACKGROUND

• 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.

  PMID: 24760270 BACKGROUND

• 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.

  PMID: 22659054 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Dominique Savary, MD

  Annecy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 18, 2016
• Study Start: February 9, 2016
• Primary Completion: July 22, 2019
• Study Completion: August 22, 2019
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

FR (2)