NCT03911908

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Dr. Serge Thal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-05-22
• Completion: 2023-05-05
• First posted: 2019-04-11
• Last updated: 2023-03-31

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study