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NCT03911908: NICA

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

Status unknown Phase 2 Last updated 31 March 2023
What this trial tests

Phase 2 trial testing Cerebral oximetry (near infrared) based CPR-Algorithm in Cardiac Arrest in 360 participants. Status unknown.

Timeline
1 July 2019
Primary endpoint
22 May 2022
5 May 2023

Quick facts

Lead sponsorDr. Serge Thal
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment360
Start date1 July 2019
Primary completion22 May 2022
Estimated completion5 May 2023
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Dr. Serge Thal

Who can join

18 and older, any sex, with Cardiac Arrest or Cardiopulmonary Arrest With Successful Resuscitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pediatric Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations.
    Maconochie IK, Aickin R, Hazinski MF, Atkins DL, et al · · 2020 · cited 45× · PMID 33098916 · DOI 10.1016/j.resuscitation.2020.09.013

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