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

May 5, 2022 updated by: Miha Košir

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between cerebral oxygenation and skeletal oxygenation values.
Time Frame: 30 minutes
coefficient
30 minutes
First measures cerebral oxygenation and skeletal oxygenation values as a predictor of ROSC.
Time Frame: 1 minute
percent
1 minute
Average values of cerebral oxygenation and skeletal oxygenation values as a predictor of ROSC.
Time Frame: 30 minutes
percent
30 minutes
Absolute change of cerebral oxygenation and skeletal oxygenation values in ROSC and NON-ROSC patients.
Time Frame: 30 minutes
percent
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miha Košir

Collaborators

University Medical Centre Ljubljana
Community Health Centre Ljubljana

Investigators

  • Principal Investigator: Matej Podbregar, MD PhD, General hospital Celje, Intensive internal medicine therapy unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMC-NIRS/CPR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Out-Of-Hospital Cardiac Arrest

Clinical Trials on NIRS device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe