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

NCT ID: NCT03911908

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-05-05

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).

Conditions

Cardiac Arrest; Cardiopulmonary Arrest With Successful Resuscitation; Cerebral Oxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ERC guided CPR (intervention/NIRS group)

CPR protocol according to current ERC guidelines (2015)

Group Type: ACTIVE_COMPARATOR

Cerebral oximetry (near infrared) based CPR-Algorithm

Intervention Type: COMBINATION_PRODUCT

If NIRS values do not increase over time until ROSC (target: \>40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.

ERC-based CPR (control group)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cerebral oximetry (near infrared) based CPR-Algorithm

If NIRS values do not increase over time until ROSC (target: \>40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.

Intervention Type: COMBINATION_PRODUCT

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Serge Thal

OTHER

Sponsor Role: lead

Responsible Party

Dr. Serge Thal

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Serge C Thal, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

Locations

Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

Other Identifiers

U1111-1231-2797

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-13666

Identifier Type: -

Identifier Source: org_study_id