Impact of NIRS-guided Cardiopulmonary Resuscitation After Cardiac Arrest on Resuscitation Rate

Study Overview
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Brief Summary
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Sudden cardiac death is one of the main causes of morbidity and mortality worldwide. Cardiac arrest requires prompt intervention by cardiopulmonary resuscitation (CPR). The resuscitation guidelines are the current recommendations for CPR and are revised by expert panels such as the European Resuscitation Council (ERC). Up to now, a parameter for assessing the quality of CPR is missing and further monitoring methods are urgently needed. Near-infrared spectroscopy (NIRS) is a portable method for measuring regional oxygen levels in the brain. Recent clinical trials suggest that cerebral oxygenation measured by NIRS may correlate with survival and outcome after cardiac arrest. The investigators propose that NIRS technology may not only be suitable to determine or predict the outcome of the patients, but could also be a useful tool to guide the CPR providers to optimize the CPR techniques and guide the individual treatments/interventions. The present study was therefore designed to determine if NIRS guided CPR with the aim to optimize NIRS values is superior compared to the current standard practice according to published CPR guidelines (return of spontaneous circulation [ROSC] rate, short and long-term cerebral performance).

Official Title
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Impact of a NIRS-guided Cardiopulmonary Resuscitation Algorithm Compared to the Current ERC-guideline Algorithm on ROSC Rate and Patient Outcome After In-hospital and Out-of-hospital Cardiac Arrest

Conditions
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Cardiac Arrest, Cardiopulmonary Arrest With Successful Resuscitation, Cerebral Oxygenation

Intervention / Treatment
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* Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a cardiac arrest from the age of 18 years (in and out-of-hospital cardiac arrest) Exclusion Criteria: post-traumatic cardiac arrest non-fitting NIRS sensor (size)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Does near-infrared spectroscopy (NIRS) technology based advanced cardiac life support improve cardiopulmonary resuscitation (CPR) quality in patients (in-house [IHCA] and out-of-hospital cardiac arrest [OHCA], randomized enrollment immediately with CPR) and thereby improve return of spontaneous circulation (ROSC) rate (primary outcome) and patient outcome compared to European Resuscitation Council (ERC)-based CPR (concealed NIRS recording).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERC guided CPR (intervention/NIRS group)<br>CPR protocol according to current ERC guidelines (2015) | Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm<br>* If NIRS values do not increase over time until ROSC (target: >40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.<br>|
| No Intervention: ERC-based CPR (control group)<br>modified CPR protocol based on current ERC guidelines (2015), extended by evaluation of NIRS readings and interventions to optimize CPR quality | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful cardiopulmonary resuscitation (CPR) | Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) [ROSC: yes/no] | DAY 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-ROSC | Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) [min] | DAY 1 | 
| Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC) | Neurofunctional recovery, total score, range: 1-5 | DAY 30, DAY 180, DAY 360 | 
| Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC) | Neurofunctional recovery, total score, range: 1-8 | DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC) | 
| The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC) | Neurofunctional recovery, total score, range: 0-100 | Discharge from intensive care unit (variable time point, depending on condition of patient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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near-infrared spectroscopy, cardiopulmonary resuscitation, cardiac arrest, cerebral oximetry