Clinical trial NCT03911908: Impact of NIRS-guided Cardiopulmonary Resuscitation After Cardiac Arrest on Resuscitation Rate
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cardiac Arrest
Cardiopulmonary Arrest With Successful Resuscitation
Cerebral Oxygenation
Keywords: near-infrared spectroscopy
cardiopulmonary resuscitation
cardiac arrest
cerebral oximetry
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: successful cardiopulmonary resuscitation (CPR)
timeFrame: DAY 1
Secondary outcomes:
measure: Time-to-ROSC
timeFrame: DAY 1
measure: Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)
timeFrame: DAY 30, DAY 180, DAY 360
measure: Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)
timeFrame: DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC)
measure: The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)
timeFrame: Discharge from intensive care unit (variable time point, depending on condition of patient)
Other outcomes:
measure: Neuron Specific Enolase (NSE) blood level after successful return of spontaneous circulation (ROSC)
timeFrame: DAY 1, DAY 2, DAY 3, DAY 4
measure: S100B blood level after successful return of spontaneous circulation (ROSC)
timeFrame: DAY 1, DAY 2, DAY 3, DAY 4
measure: plasminogen activator inhibitor 1/2 (PAI1/2) blood level after successful return of spontaneous circulation (ROSC) after successful return of spontaneous circulation (ROSC) after successful return of spontaneous circulation (ROSC)
timeFrame: DAY 1, DAY 2, DAY 3, DAY 4
measure: proBNDF/BDNF blood level after successful return of spontaneous circulation (ROSC)
timeFrame: DAY 1, DAY 2, DAY 3, DAY 4
measure: Neurofilament blood level after successful return of spontaneous circulation (ROSC)
timeFrame: DAY 1, DAY 2, DAY 3, DAY 4
Locations:
city: Mainz
country: Germany
facility: Medical Center of the Johannes Gutenberg-University Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: Department of Anesthesiology
name: Serge C Thal, MD
role: PRINCIPAL_INVESTIGATOR
References: