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Clinical Trials/NCT03911908
NCT03911908
Active, not recruiting
Phase 2

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

Dr. Serge Thal1 site in 1 country360 target enrollmentJuly 1, 2019

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
Dr. Serge Thal
Enrollment
360
Locations
1
Primary Endpoint
successful cardiopulmonary resuscitation (CPR)
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
May 5, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Serge Thal
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Serge Thal

Principal Investigator

Johannes Gutenberg University Mainz

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)

Outcomes

Primary Outcomes

successful cardiopulmonary resuscitation (CPR)

Time Frame: DAY 1

Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) \[ROSC: yes/no\]

Secondary Outcomes

  • Time-to-ROSC(DAY 1)
  • Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)(DAY 30, DAY 180, DAY 360)
  • Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)(DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC))
  • The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)(Discharge from intensive care unit (variable time point, depending on condition of patient))

Study Sites (1)

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