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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiopulmonary Arrest With Successful Resuscitation; Cardiac Arrest; Cerebral Oxygenation
• Intervention / Treatment: Combination product: Cerebral oximetry (near infrared) based CPR-Algorithm

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Medical Center of the Johannes Gutenberg-University Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ERC guided CPR (intervention/NIRS group); CPR protocol according to current ERC guidelines (2015)	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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-ROSC	Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) [min]	DAY 1
Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)	Neurofunctional recovery, total score, range: 1-5	DAY 30, DAY 180, DAY 360
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Dr. Serge Thal
• Investigators: Principal Investigator: Serge C Thal, MD, Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): May 22, 2022
• Study Completion (Anticipated): May 5, 2023

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cardiac arrest; near-infrared spectroscopy; cardiopulmonary resuscitation; cerebral oximetry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2018-13666; U1111-1231-2797 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes