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

Cardiac Arrest Clinical Trial

— NICA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03911908
• Other study ID #: 2018-13666
• Secondary ID: U1111-1231-2797
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: May 5, 2023

Study information

• Verified date: March 2023
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: May 5, 2023
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Arrest With Successful Resuscitation
• Cerebral Oxygenation
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
Germany	Medical Center of the Johannes Gutenberg-University Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Serge Thal

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neuron Specific Enolase (NSE) blood level after successful return of spontaneous circulation (ROSC)	NSE as marker for brain damage after cardiac arrest	DAY 1, DAY 2, DAY 3, DAY 4
Other	S100B blood level after successful return of spontaneous circulation (ROSC)	S100B as marker for brain damage after cardiac arrest	DAY 1, DAY 2, DAY 3, DAY 4
Other	plasminogen activator inhibitor 1/2 (PAI1/2) blood level after successful return of spontaneous circulation (ROSC) after successful return of spontaneous circulation (ROSC) after successful return of spontaneous circulation (ROSC)	PAI1/2 as marker for brain damage after cardiac arrest	DAY 1, DAY 2, DAY 3, DAY 4
Other	proBNDF/BDNF blood level after successful return of spontaneous circulation (ROSC)	proBNDF/BDNF as marker for brain damage after cardiac arrest	DAY 1, DAY 2, DAY 3, DAY 4
Other	Neurofilament blood level after successful return of spontaneous circulation (ROSC)	Neurofilament as marker for brain damage after cardiac arrest	DAY 1, DAY 2, DAY 3, DAY 4
Primary	successful cardiopulmonary resuscitation (CPR)	Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) [ROSC: yes/no]	DAY 1
Secondary	Time-to-ROSC	Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) [min]	DAY 1
Secondary	Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)	Neurofunctional recovery, total score, range: 1-5	DAY 30, DAY 180, DAY 360
Secondary	Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)	Neurofunctional recovery, total score, range: 1-8	DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC)
Secondary	The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)	Neurofunctional recovery, total score, range: 0-100	Discharge from intensive care unit (variable time point, depending on condition of patient)