Non-invasive Neurological Evaluation During CPR

Cardiac Arrest Clinical Trial

— Neuro-E-CPR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684955
• Other study ID #: Neuro-E-CPR
• Status: Completed
• Start date: February 2, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
France	SAMU 74	Annecy
France	SAMU 38	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

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 r — View Citation

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. — View Citation

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 — View Citation

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: 10.11 — View Citation

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):10 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival status at hospital admission	Alive patients at hospital admission	hospital admission - Day 1
Secondary	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
Secondary	Survival status at hospital discharge	Alive patients at hospital discharge	up to 30 days if still hospitalized
Secondary	Survival status at Day 30	Vital status at 30 days	Day 30
Secondary	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