Tissue Oxygenation During Cardiopulmonary Resuscitation as a Predictor of Return of Spontaneous Circulation

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

Cerebral and Skeletal Muscle Oxygenation During Cardiopulmonary Resuscitation as a Predictor of Return of Spontaneous Circulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058925
• Other study ID #: UMC-NIRS/CPR
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2022
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of the trial is to find out if there is correlation between cerebral and skeletal muscle oxygenation values during cardiopulmonary resuscitation and if these values can predict return of spontaneous circulation. The investigators would like to find out which values, first measures, average, maximal, are better predictor of return of spontaneous circulation. All the patients with nontraumatic cardiac arrest in prehospital environment will be enrolled in the study. The measurements will be taken with NIRS device and special electrodes, which will be placed on patient's forehead and thenar eminence od right hand. No ALS procedure will be modified.

Description:

Out of hospital cardiac arrest (OHCA) is major cause of morbidity and mortality around the world. Annually there is around 350.000 deaths in the Europe because of OHCA. Despite a great progress in prehospital and emergency medicine in recent years, there is no major increase in surviving OHCA. There are many factors which influence to the end result of OHCA. Till now we still don't know how to predict the outcome of cardiac arrest in early phase of cardiopulmonary resuscitation (CPR).

Today emergency teams use end-tidal CO2 values (etCO2) as an indirect marker of cardiac output and as an auxiliary indicator of return of spontaneous circulation (ROSC). Higher values are also correlated with greater probability of ROSC.

Studies in recent years showed that there could be another method which could help to predict the result of OHCA. Near-infrared spectroscopy (NIRS) is a noninvasive spectroscopic method, which uses light near to infrared electromagnetic spectrum of light. The device can, based on Beer-Lambert law, calculates tissue oxygenation of underlaid tissue. It is also useful in the states, where there is little or even no blood flow (cardiac arrest). NIRS is currently used in operating rooms and ICU, but there is also option to use it in prehospital environment. During cardiac arrest the blood flow through organs is very low or absent. This causes hypoxic-ischemic brain injury and also injury of other vital organs. Based on previous studies with NIRS, we can measure cerebral oxygenation by placing electrodes on patient's forehead. Patients with higher values had greater probability of ROSC. It is presumed, that NIRS values are indirect indicator of coronary perfusion pressure. It is known that higher coronary perfusion pressure is connected with higher oxygen concentration in the brain during cardiac arrest. NIRS can also predict re-arrest even before losing a pulse.

Till today there are no studies which would look for correlation between cerebral and skeletal oxygenation during cardiac arrest.

The investigator's study is monocentric, prospective, observational, nonrandomized taking place at Emergency department of University Medical Centre Ljubljana (UMC Ljubljana). There is also a Basic emergency first aid infirmary (Unit SNMP) of Community Health Centre Ljubljana, which will with it's prehospital units make the measurements. After an eyewitness of cardiac arrest will call on emergency number 112 a medical dispatcher will activate medical team with emergency doctor and send them to the location. Upon arrival the team will start CPR based on ALS protocol. As soon as possible one of team members will put two NIRS electrodes on the patient - one on the patient's forehead and the other on patient's thenar eminence on the hand. ALS protocol will not be modified in any way. The NIRS device (Nonin SenSmart Model X-100) will be turned on till the end of resuscitation or till arrival to the hospital (UMC Ljubljana).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• non-traumatic cardiac arrest in prehospital environment

• age 18 years or more

Exclusion Criteria:

• age 18 years or less

• pregnancy

• traumatic cause of cardiac arrest

• hypothermia

• drowning

• E-CPR protocol (candidates for ECMO CPR)

• spontaneous circulation upon arrival of emergency team at the scene

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• NIRS device
Application of NIRS electrode to forehead and thenar eminence.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (3)

Lead Sponsor	Collaborator
Miha Košir	Community Health Centre Ljubljana, University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (17)

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Friess SH, Sutton RM, French B, Bhalala U, Maltese MR, Naim MY, Bratinov G, Arciniegas Rodriguez S, Weiland TR, Garuccio M, Nadkarni VM, Becker LB, Berg RA. Hemodynamic directed CPR improves cerebral perfusion pressure and brain tissue oxygenation. Resuscitation. 2014 Sep;85(9):1298-303. doi: 10.1016/j.resuscitation.2014.05.040. Epub 2014 Jun 16. — View Citation

Frisch A, Suffoletto BP, Frank R, Martin-Gill C, Menegazzi JJ. Potential utility of near-infrared spectroscopy in out-of-hospital cardiac arrest: an illustrative case series. Prehosp Emerg Care. 2012 Oct-Dec;16(4):564-70. doi: 10.3109/10903127.2012.702191. Epub 2012 Jul 23. — View Citation

Genbrugge C, De Deyne C, Eertmans W, Anseeuw K, Voet D, Mertens I, Sabbe M, Stroobants J, Bruckers L, Mesotten D, Jans F, Boer W, Dens J. Cerebral saturation in cardiac arrest patients measured with near-infrared technology during pre-hospital advanced life support. Results from Copernicus I cohort study. Resuscitation. 2018 Aug;129:107-113. doi: 10.1016/j.resuscitation.2018.03.031. Epub 2018 Mar 23. — View Citation

Genbrugge C, Meex I, Boer W, Jans F, Heylen R, Ferdinande B, Dens J, De Deyne C. Increase in cerebral oxygenation during advanced life support in out-of-hospital patients is associated with return of spontaneous circulation. Crit Care. 2015 Mar 24;19:112. doi: 10.1186/s13054-015-0837-5. — View Citation

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Jones S, Chiesa ST, Chaturvedi N, Hughes AD. Recent developments in near-infrared spectroscopy (NIRS) for the assessment of local skeletal muscle microvascular function and capacity to utilise oxygen. Artery Res. 2016 Dec;16:25-33. Review. — View Citation

Kalkan A, Bilir O, Ersunan G, Ozel D, Tas M, Memetoglu ME. Abdominal oxygen saturation for monitoring return of spontaneous circulation in out-of-hospital cardiac arrest using near infrared spectrophometry. Am J Emerg Med. 2015 Mar;33(3):344-8. doi: 10.1016/j.ajem.2014.11.029. Epub 2014 Nov 28. — 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. — View Citation

Možina H, Podbegar M. Near-infrared spectroscopy for evaluation of global and skeletal muscle tissue oxygenation. World J Cardiol. 2011 Dec 26;3(12):377-82. doi: 10.4330/wjc.v3.i12.377. — View Citation

Mozina H, Podbregar M. Near-infrared spectroscopy during stagnant ischemia estimates central venous oxygen saturation and mixed venous oxygen saturation discrepancy in patients with severe left heart failure and additional sepsis/septic shock. Crit Care. 2010;14(2):R42. doi: 10.1186/cc8929. Epub 2010 Mar 23. — View Citation

Prosen G, Strnad M, Doniger SJ, Markota A, Stožer A, Borovnik-Lesjak V, Mekiš D. Cerebral tissue oximetry levels during prehospital management of cardiac arrest - A prospective observational study. Resuscitation. 2018 Aug;129:141-145. doi: 10.1016/j.resuscitation.2018.05.014. Epub 2018 May 12. — View Citation

Sandroni C, Cariou A, Cavallaro F, Cronberg T, Friberg H, Hoedemaekers C, Horn J, Nolan JP, Rossetti AO, Soar J. Prognostication in comatose survivors of cardiac arrest: an advisory statement from the European Resuscitation Council and the European Society of Intensive Care Medicine. Resuscitation. 2014 Dec;85(12):1779-89. Review. — View Citation

Sasson C, Rogers MA, Dahl J, Kellermann AL. Predictors of survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):63-81. doi: 10.1161/CIRCOUTCOMES.109.889576. Epub 2009 Nov 10. Review. — View Citation

Schnaubelt S, Sulzgruber P, Menger J, Skhirtladze-Dworschak K, Sterz F, Dworschak M. Regional cerebral oxygen saturation during cardiopulmonary resuscitation as a predictor of return of spontaneous circulation and favourable neurological outcome - A review of the current literature. Resuscitation. 2018 Apr;125:39-47. doi: 10.1016/j.resuscitation.2018.01.028. Epub 2018 Feb 2. Review. — 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: 10.1136/emermed-2013-203467. Epub 2014 Mar 24. — View Citation

Wik L. Near-infrared spectroscopy during cardiopulmonary resuscitation and after restoration of spontaneous circulation: a valid technology? Curr Opin Crit Care. 2016 Jun;22(3):191-8. doi: 10.1097/MCC.0000000000000301. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between cerebral oxygenation and skeletal oxygenation values.	coefficient	30 minutes
Primary	First measures cerebral oxygenation and skeletal oxygenation values as a predictor of ROSC.	percent	1 minute
Primary	Average values of cerebral oxygenation and skeletal oxygenation values as a predictor of ROSC.	percent	30 minutes
Primary	Absolute change of cerebral oxygenation and skeletal oxygenation values in ROSC and NON-ROSC patients.	percent	30 minutes