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

NCT04058925 | Completed

• 1 other identifier: UMC-NIRS/CPR
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Out-Of-Hospital Cardiac Arrest; Near-infrared spectroscopy

Outcome Measures

Primary Outcomes (4)

• Correlation between cerebral oxygenation and skeletal oxygenation values.

  coefficient

  30 minutes

• First measures cerebral oxygenation and skeletal oxygenation values as a predictor of ROSC.

  percent

  1 minute

• Average values of cerebral oxygenation and skeletal oxygenation values as a predictor of ROSC.

  percent

  30 minutes

• Absolute change of cerebral oxygenation and skeletal oxygenation values in ROSC and NON-ROSC patients.

  percent

  30 minutes

Interventions

NIRS device DEVICE

Application of NIRS electrode to forehead and thenar eminence.

Eligibility Criteria

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

Study Population

The adult population of city Ljubljana and surrounding municipality is which the emergency first aid is provided by Basic emergency first aid infirmary of Community Health Centre Ljubljana. The area is 1670 km2 big and there are up to 450.000 people.

You may qualify if:

• non-traumatic cardiac arrest in prehospital environment
• age 18 years or more

You may not qualify if:

• 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

Sponsors & Collaborators

• Miha Košir: lead
• University Medical Centre Ljubljana: collaborator
• Community Health Centre Ljubljana: collaborator

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (18)

• Grasner JT, Bottiger BW, Bossaert L; European Registry of Cardiac Arrest (EuReCa) ONE Steering Committee; EuReCa ONE Study Management Team. EuReCa ONE - ONE month - ONE Europe - ONE goal. Resuscitation. 2014 Oct;85(10):1307-8. doi: 10.1016/j.resuscitation.2014.08.001. Epub 2014 Aug 15. No abstract available.

  PMID: 25132474 BACKGROUND

• 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.

  PMID: 20123673 BACKGROUND

• 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. doi: 10.1016/j.resuscitation.2014.08.011.

  PMID: 25438253 BACKGROUND

• 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(1):112. doi: 10.1186/s13054-015-0837-5.

  PMID: 25887259 BACKGROUND

• 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.

  PMID: 22823984 BACKGROUND

• Cournoyer A, Iseppon M, Chauny JM, Denault A, Cossette S, Notebaert E. Near-infrared Spectroscopy Monitoring During Cardiac Arrest: A Systematic Review and Meta-analysis. Acad Emerg Med. 2016 Aug;23(8):851-62. doi: 10.1111/acem.12980.

  PMID: 27028004 BACKGROUND

• Prosen G, Strnad M, Doniger SJ, Markota A, Stozer A, Borovnik-Lesjak V, Mekis 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.

  PMID: 29763712 BACKGROUND

• 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. doi: 10.1016/j.artres.2016.09.001.

  PMID: 27942271 BACKGROUND

• 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.

  PMID: 20331856 BACKGROUND

• 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.

  PMID: 29410191 BACKGROUND

• 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.

  PMID: 27054625 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

• 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.

  PMID: 25559313 BACKGROUND

• Mozina 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.

  PMID: 22216373 BACKGROUND

• 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.

  PMID: 24945902 BACKGROUND

• 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

• 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.

  PMID: 29580958 BACKGROUND

• Kosir M, Mozina H, Podbregar M. Skeletal muscle oxygenation during cardiopulmonary resuscitation as a predictor of return of spontaneous circulation: a pilot study. Eur J Med Res. 2023 Oct 11;28(1):418. doi: 10.1186/s40001-023-01393-z.

  PMID: 37821950 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Matej Podbregar, MD PhD

  General hospital Celje, Intensive internal medicine therapy unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Emergency medicine resident

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: September 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

SL (1)