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

Dr. Serge Thal

Status and phase: Active, not recruiting; Phase 2

Conditions: Cardiopulmonary Arrest With Successful Resuscitation; Cardiac Arrest; Cerebral Oxygenation

Treatments: Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT03911908

U1111-1231-2797 (Registry Identifier)

2018-13666

Details and patient eligibility

About

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).

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 2 patient groups

ERC guided CPR (intervention/NIRS group)

Active Comparator group

Description:

CPR protocol according to current ERC guidelines (2015)

Treatment:

Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm

ERC-based CPR (control group)

No Intervention group

Description:

modified CPR protocol based on current ERC guidelines (2015), extended by evaluation of NIRS readings and interventions to optimize CPR quality